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Two articles of interest

BluebirdOne's picture
BluebirdOne
Posts: 194
Joined: Jul 2018

 

Reulators cite care deficiencies at MD Anderson after patient's adverse event. 

https://www.houstonchronicle.com/news/houston-texas/houston/article/Regulators-cite-care-deficiencies-at-MD-Anderson-13969785.php

This was a scary article to read as it seems like the deficiencies were major for Medicare to get involved. 

 

Radiation Plus Chemotherapy doesn't improve endometrial recurrence-free survival.  (A study from Northwestern University which will be published in the New England Journal of Medicene June 12, 2019)

https://medicalxpress.com/news/2019-06-chemotherapy-doesnt-endometrial-cancer-recurrence-free.html

The initial article does not state exactly what type of cancer, but it seems to be type 1, and the study was done on stage III and IV uterine cancers. I don't have a link to the Journal's article. 

 

 

 

Forherself's picture
Forherself
Posts: 168
Joined: Jan 2019

This article makes me sad.  MD Anderson is a premiere cancer center.   It does 200,000 blood product treatments a year.  It sounds like one had a bad outcome.  It could be as simple as an employee making a mistake.   And then the oversight doctor says this makes them wonder if the hospital is safe for Medicare pateints.  Nothing is perfect.   Where would all those patients be treated go.  There are not hospitals standing by.   Work with MD Anderson.   They do millions of things right.

MAbound
Posts: 847
Joined: Jun 2016

It just goes to show you that it's best to spend as little time in the hospital, any hospital, as is possible.

One, they are hot beds of infections.

Two, you are likely to get better care at home because,

Three, there's never the kind of staffing to get the kind of care you need and should get, so what's the point? 

To newbies, if you do get stuck staying in a hospital after surgery, push yourself to get up an walk because that will help you to get sent home quicker.

zsazsa1
Posts: 311
Joined: Oct 2018

Anyone have access to NEJM for the full article?  It would be very interesting to see if they analysed the results according to type of endometrial cancer.

Forherself's picture
Forherself
Posts: 168
Joined: Jan 2019

they are talking about endometrioid too when they use the term "endometrial cancer".   Since the outcomes of endometrioid and more aggressive endometrial cancers are so different, I think including both in any trial makes the data less meaningful for both groups.   And this article uses ther term "endometrial cancer".   BUT at the bottom of the page is another link to an article about high risk endometrial cancers that I think you would find helpful.   

LisaPizza's picture
LisaPizza
Posts: 208
Joined: Feb 2018

A more detailed article about the study:

News > Medscape Medical News > Oncology News

Chemo Alone in Advanced Endometrial Cancer?

Roxanne Nelson, RN, BSN
June 12, 2019

 

Among patients with advanced endometrial carcinoma, chemotherapy plus radiation was not associated with longer relapse-free survival than chemotherapy alone, according to new findings.

 

At 60 months, 59% of patients were alive and relapse free in the chemoradiotherapy group, vs 58% in the chemotherapy-only group (hazard ratio [HR], 0.90).

 

"Radiation has been used historically in this group of patients who are considered to be at high risk of both local and distant metastasis," said lead author Daniela Matei, MD, Diana Princess of Wales Professor in Cancer Research, Department of Obstetrics and Gynecology, Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois.

 

"After the results of a previous study (GOG 122) that were reported approximately 15 years ago, systemic chemotherapy started to be included in the treatment of this patient population along with radiation," she told Medscape Medical News.

 

"The results of the current study (GOG 258) show that the combined-modality regimen did not result in an improvement in recurrence-free survival over chemotherapy alone and confirm the benefit of chemotherapy alone for patients with stage III uterine cancer," she said.

 

The study was published online June 13 in the New England Journal of Medicine.

Approached for comment, Kevin Holcomb, MD, associate professor of clinical obstetrics and gynecology at Weill Cornell Medical College, New York City, said that radiation has been a mainstay of treatment for endometrial cancer, but this is changing.

 

If you can get the same result by using one therapy, there is no reason to use two.Dr Kevin Holcomb

 

"In general, in cancer care, if you can get the same result by using one therapy, there is no reason to use two," he told Medscape Medical News. "If survival is similar, then you need to look at quality of life, and this will question the benefit of adding radiation."

 

Radiation and/or Chemotherapy

 

Pelvic or whole-abdominal radiotherapy has traditionally been used after surgical resection. Although it prevents pelvic recurrence, it has been less effective for preventing systemic recurrence, Matei explained. A randomized trial conducted by the Gynecologic Oncology Group (GOG) found that chemotherapy was superior to radiotherapy for treating locally advanced disease, and it subsequently became part of the standard protocol (J Clin Oncol. 2006;24:36-44).

 

However, chemotherapy alone has been associated with an increased risk for locoregional recurrence. Thus, note the authors, it was logical to hypothesize that the combined strategy might improve outcomes by preventing both local (pelvic) and distant recurrences.

 

Guidelines on the diagnosis, treatment, and follow-up of endometrial cancer were issueda few years ago by the European Society for Medical Oncology, the European Society for Radiotherapy and Oncology, and the European Society of Gynaecological Oncology.

 

"The most controversial areas related to the indications for brachytherapy or external-beam radiotherapy and the use of chemotherapy combined with, or instead of, radiotherapy," the lead author of the guidelines, Nicoletta Colombo, MD, from the European Institute of Oncology, University of Milan-Bicocca, Italy, told Medscape Medical News at the time.

 

For example, one previous study in women with early-stage, high-risk endometrial cancer showed that adding chemotherapy to radiotherapy was not superior to the standard treatment of radiotherapy alone.

 

No Difference in Treatment Arms

 

In the current trial (GOG 258), Matei and her colleagues evaluated the use of concurrent tumor volume–directed external-beam radiotherapy and chemotherapy compared with chemotherapy alone in women with advanced-stage endometrial cancer.

 

A total of 707 patients with stage III or IVA endometrial carcinoma were randomly assigned to receive either chemoradiotherapy (n = 346) or chemotherapy only (n = 361).

 

The chemoradiotherapy regimen included cisplatin (50 mg/m2 administered intravenously on days 1 and 29) and volume-directed external-beam radiotherapy, followed by carboplatin (dosed to achieve an area under the concentration–time curve [AUC] of 5 to 6 ) plus paclitaxel (175 mg/m2administered every 21 days for four cycles). The chemotherapy-only regimen consisted of carboplatin (to achieve an AUC of 6) plus paclitaxel (175 mg/m2 given every 21 days for six cycles).

 

The results for the primary endpoint of relapse-free survival did not reach significance. The null hypothesis that chemoradiotherapy is not superior to chemotherapy alone could not be rejected (P = .20 by one-tailed test).

 

To date, there have been a total 165 deaths — 86 in the chemoradiotherapy group, and 79 in the chemotherapy-only group. In the chemoradiotherapy group, 73% deaths occurred as a result of the progression of endometrial cancer progression; in the chemotherapy-only group, 81% such deaths occurred. However, between-group comparisons of overall survival could not be made because the data are not sufficiently mature, the authors comment.

 

Exploratory subgroup analyses failed to identify a subgroup of patients who may have benefited more from chemoradiotherapy than from chemotherapy alone.

 

Other analyses showed that the cumulative incidence of vaginal disease recurrence at 60 months was 2% in the chemoradiotherapy group and 7% in the chemotherapy-only group (HR, 0.36). For pelvic or para-aortic node recurrence, the cumulative incidence was 11% with chemotherapy-only, vs 20% with chemoradiotherapy (HR, 0.43).

 

The cumulative incidence of distant recurrence at 60 months' follow-up was 27% in the chemoradiotherapy group and 21% in the chemotherapy-only group (HR, 1.36). Coincident local and distant recurrences at first presentation were found in 2.2% and 4.9%, respectively.

 

Adverse events of grade 3 or greater were reported in 202 patients (58%) in the chemoradiotherapy group and 227 patients (63%) in the chemotherapy-only group. Both groups reported symptoms of neurotoxicityin association with treatment.

 

"Physicians may consider addition of radiation for selected patients considered at very high risk for local recurrence," said Matei. "However, completion of systemic chemotherapy in all patients remains key to achieving best outcomes."

 

Doesn't Close the Door

 

Commenting to Medscape Medical News, Holcomb said that radiotherapy has historically had a role in the adjuvant treatment in locally advanced endometrial cancer and has been the mainstay therapy for many years.

 

However, he pointed out that radiotherapy "has never been shown to improve overall survival, and many patients had distant recurrences that were not likely to be prevented by radiation."

 

Then the GOG 122 trial changed things. Whole-abdominal irradiation was compared with doxorubicin-cisplatin chemotherapy in women with stage III or IV endometrial carcinoma. "Many of us thought that radiation would be proven superior, given its historical role, but that wasn't the case," said Holcomb. "There was a significant improvement in survival with chemotherapy."

 

Although the current study used relapse-free survival as an endpoint, it is unlikely this will translate to a difference in survival between the two groups, he said.

 

In addition, although the chemotherapy group experienced a higher rate of adverse effects, these were acute events, whereas for the combination group, the rate of long-term events was higher. "While we always strive to limit acute toxicities during treatment," he said, "we really want to avoid the ones that 'hang around' long term."

 

However, Holcomb also noted that even though this study demonstrated that chemoradotherapy was not superior to chemotherapy alone, it does not close the door entirely on combination therapy.

 

"The study only looked at one way that chemotherapy and radiation therapy can be combined," he said. "There are other ways to give combination therapy."

 

For example, one method is to "sandwich" radiotherapy in between treatments with chemotherapy — give half of the chemotherapy, then give the radiation, and then give the remaining cycles. Another method is to administer chemotherapy and combination therapy sequentially. "We need better data on these methods, which will probably be studied in future trials," he said.

 

Unanswered Questions

 

Another expert feels that this is a complex topic and that the article leaves a number of questions unanswered. "Combined therapy is frequently used to treat subsets of patients included in this trial, and retrospective studies have repeatedly strongly suggested that radiation therapy is important for the subset of patients with involved nodes," said Patricia Eifel, MD, professor, Department of Radiation Oncology, Division of Radiation Oncology, the University of Texas MD Anderson Cancer Center, Houston. "These represented about 75% of patients."

 

She also pointed out that these results "certainly indicate that patients treated in the ways employed in this trial had similar relapse rates with or without radiation therapy. However, there is a lot of missing information in this study, which makes it difficult to know how to generalize the results to high, modern, optimized, multidisciplinary practice."

 

Eifel said that there is reason to think the radiotherapy given in the trial may not have been optimal, although the details are sparse. For example, the authors do not fully explain what was meant by "volume-directed RT," and that needs to be clarified.

 

More importantly, the maximum dose delivered was 45 Gy, even if there was gross residual disease (anything ≥1 cm), and "45 Gy would rarely be expected to control nodes of this size, even when combined with chemotherapy," she said. "It may seem that this would have little impact, since the rate of gross residual reported in the paper (2%) is so low. However, in our experience, this 2% rate is much lower than expected, particularly in a population that was not required to have a full, or even any, lymph node dissection."

 

The article did not clearly outline how patients were assessed for residual disease, she continued. Because postoperative imaging was not required, it must be assumed that assessment was based on surgical findings, she said. "In our experience, surgical assessment is inadequate, because some of the most frequently involved sites are behind the renal, aortocaval, and iliac vessels," said Eifel. "We often find residual positive or suspicious nodes on postoperative imaging, even when the surgeon failed to appreciate residual disease."

 

Eifel added that adjuvant radiotherapy is almost always ineffective for treating gross residual disease if the dose is not boosted higher, usually to 60 Gy. "This was not permitted in the trial, even if gross residual was known to be present," she noted.

 

The study was supported by grants from the National Cancer Institute (NCI) to the Gynecologic Oncology Group Administrative Office, the Gynecologic Oncology Group Statistical and Data Center, NRG Oncology, NRG Operations, and the NCI Community Oncology Research Program. Matei has received personal fees and nonfinancial support from Genentech, AstraZeneca, Clovis, Astex Inc, and the European Commission, and personal fees from Tesaro, all outside the submitted work. Several coauthors have also reported relationships with industry. Eifel has disclosed no relevant financial relationships.

 

N Engl J Med. Published online June 13, 2019. Abstract

Medscape Medical News © 2019 
Cite this: Chemo Alone in Advanced Endometrial Cancer? - Medscape - Jun 12, 2019

All material on this website is protected by copyright, Copyright © 1994-2019 by WebMD LLC. This website also contains material copyrighted by 3rd parties.

evolo58
Posts: 293
Joined: Dec 2017

So my onco at the time was right in not doing radiation as immediate frontline (though it might have helped months later, back when the cancer was controlled in a smaller area). 

However, I thought I saw another article that supported chemo and radiation for Stage 4 patients like me, so go figure. 

Armywife's picture
Armywife
Posts: 276
Joined: Feb 2018

Lisa, this is so interesting to me.  I went to MD Anderson for my second opinion - my pathology here in San Antonio came back as Stage IIIA, Grade 1.  MD Anderson's review indicated Stage IVB, Grade 2 endometriod endometrial with a positive pelvic wash and lymphvascular invasion.    I had chemo after surgery, and then considered radiation.  The rad/onc here at our military hospital was awesome - he planned external radiation and brachy.  I asked him if he could show me any studies that indicated radiation would prolong my survival, because all I was seeing were lots of damage like Cheese has had, and no hard data to recommend radiation.  He very kindly said he couldn't.  I asked for MD Anderson's opinion, and their tumor board was split down the middle.  Dr Eifel, mentioned above, is world renowned and though I didn't get to meet her, my gyn/onc at MD Anderson went to her to ask her opinion.  She said that since my CT scan after chemo showed NED, I'd be only getting a preventive dose of radiation rather than a treatment dose (I think that's what she's talking about above with the 45 vs 60), and that she would probably reserve radiation for recurrence.  I trusted that advice and didn't have radiation, and thus far I have no regrets.  I am 20 months NED and hopeful.  I also know it easily could have gone the other way, and at first i had to fight the feeling that I wasn't doing everything I could to fight.

DebiR
Posts: 37
Joined: Jul 2014

I participated in the GOG 258 study.  I was having a difficult time with not having radiation as I wanted to do everything possible to kick my UPSC 3A to the curb but at the same time worried about the side effects of radiation.  I left it it to the luck of the draw and  I think I was fortunate that I was randomized to the group with chemo only and did not receive any radiation.  The end of October will be 5 years since I finished chemo.  So far so good....

Debi

Armywife's picture
Armywife
Posts: 276
Joined: Feb 2018

What an encouragement that is to hear! 5 years!!!  Thank you for sharing!

LisaPizza's picture
LisaPizza
Posts: 208
Joined: Feb 2018

Here is the link to Clinical Trials.gov showing they took clear cell,  serous, and undifferentiated. 

 

Clinical trial information: NCT00942357

http://clinicaltrials.gov/show/NCT00942357

 

NoTimeForCancer's picture
NoTimeForCancer
Posts: 2562
Joined: Mar 2013

I believe they are talking about Type 1, the "garden variety type": Endometrial cancer, which begins in the uterus, is the most common gynecologic cancer with most cases occurring in women after age 55. About 62,000 new cases will be diagnosed this year. Occurrence of and mortality from endometrial cancer is rising, which may be tied to the obesity epidemic, Matei said.

 

It also looks like it was a trial with Grade III/IVA

MoeKay
Posts: 201
Joined: Feb 2004

NoTime, I've been reading for years that the reason for the increased mortality from endometrial cancer is the "obesity epidemic."  However, this does not make any sense to me whatsoever.  I could buy the fact that obesity or being overweight could play a role in the increased incidence (number of new cases diagnosed each year).  However, if the so-called "garden variety" endometrial cancer which is fueled by estrogen is as easily-curable as they claim it is, why would MORTALITY rates also be steadily rising?  It seems to me that if obesity is the cause of the rise in incidence, the mortality or death rate for this alleged easily-cured cancer would remain stable, or decrease, given advances in treatment.  So despite what Matei and many others say, I'm still not buying the connection between mortality and obesity.  Just my humble opinion. 

NoTimeForCancer's picture
NoTimeForCancer
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Joined: Mar 2013

 Moe, I can't say.  I have to say, I was in Dallas/Ft Worth this week and was able to catch up with my BFF who was in town for an Oracle convention, and I was shocked by the obsese individuals. I realize how people have struggled with this their entire life, but it can also has affiliated health issues as a result.  Having read a lot, I am sure you have seen this:

 https://www.cancer.gov/about-cancer/causes-prevention/risk/obesity/obesity-fact-sheet 

MAbound
Posts: 847
Joined: Jun 2016

Obesity is an important piece of the puzzle, but looking at an overweight person and saying that their weight is the cause of their getting cancer is probably too simplistic. Environmental and genetic factors cannot be dismissed. Just try identifying the endocrine disruptors you get exposed to in your life much less try to eliminate them and you'll get a sense of that. Some endocrine disruptors are also known as "obesogens" so there's that issue, too!

NoTimeForCancer's picture
NoTimeForCancer
Posts: 2562
Joined: Mar 2013

Totally agree, MA.  There seems to be just an explosion of cancer and even childhood diabetes.  What are we doing?  With our additives and plastics and chemicals, have we poisoned ourselves?  

zsazsa1
Posts: 311
Joined: Oct 2018

I can tell you that the explosion of Type II diabetes in children is entirely due to the great increase in morbid obesity.  Even a 5% weight loss in those children leads to remission of the diabetes.

Endometrioid uterine cancer is driven by estrogen, which, in addition to being produced by the ovaries, is produced by fat cells.

From what I've been told, UPSC and clear cell are not estrogen-related, so it is not believed that they are related to obesity.  But the incidence of these uterine cancers is also increasing.

MoeKay
Posts: 201
Joined: Feb 2004

I agree that obesity is an increasingly troubling public health issue and that it likely plays a role in the majority of endometrial cancer cases.  However, in the recent study NoTime posted a link to by Dr. Clarke at the National Cancer Institute, the author states:

"Our analysis of hysterectomy-corrected uterine cancer incidence rates among women age 30 to 79 years shows that rising rates are largely a result of the rapid increase of nonendometrioid subtypes among all racial and ethnic groups. Our data are in line with a recent study of hysterectomy-corrected uterine cancer incidence in Denmark, which showed increasing rates of nonendometrioid but not endometrioid carcinomas.  Endometrioid carcinomas are more likely to be diagnosed at an early stage, with good overall survival; they are described as estrogen dependent and are more strongly associated with obesity.  In contrast, patients with nonendometrioid carcinomas have worse survival, and risk has been less strongly associated with estrogen-related risk factors and obesity.  Thus, the observed increases in nonendometrioid cancer incidence, combined with more stable rates of endometrioid cancers, challenge the prevailing hypothesis that the obesity epidemic and changing prevalence of hormonal risk factors are major contributors to rising uterine cancer incidence. Identifying risk factors and exposures more specifically associated with nonendometrioid cancers is needed to better understand the strong increases in this subtype and potentially address racial disparities."  (bolding added by MoeKay)

Dr. Clarke's study findings make more sense to me with respect to the increased mortality rate, which I do not believe has been adequately addressed before.  I have watched both incidence and mortality rate increase since my diagnosis 20 years ago.  While others have tried to explain the increase in incidence as being fueled by obesity, no one has explained to my satisfaction why, if that is the case, the mortality rate (percentage of women dying from disease) was also increasing.  Hopefully, Dr. Clarke's study will open the door for other researchers to attempt to get to the bottom of the issue.

LisaPizza's picture
LisaPizza
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I didn't find where it said how many type 2 were enrolled,  but they were eligible, and could be stage 1 or 2,  whereas all others had to be stage 3 or 4.

 

Inclusion Criteria:

  • All patients with surgical stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria including clear cell and serous papillary and undifferentiated carcinoma

  • Patients with FIGO 2009 surgical stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology.
BluebirdOne's picture
BluebirdOne
Posts: 194
Joined: Jul 2018

Thanks for posting the full article and clarification. 

I found this in the study results tab:   

Endometrial Cancer Grades   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 370 participants 366 participants 736 participants
Endometrioid Grade 1  
87
  23.5%
79
  21.6%
166
  22.6%
Endometrioid Grade 2  
103
  27.8%
118
  32.2%
221
  30.0%
Endometrioid Grade 3  
66
  17.8%
62
  16.9%
128
  17.4%
Serous  
66
  17.8%
65
  17.8%
131
  17.8%
Clear Cell  
10
   2.7%
12
   3.3%
22
   3.0%
Other  
38
  10.3%
30
   8.2%
68
   9.2%
 
[1]

 

Measure Description: Grade 1 is 5% or less of a non-squamous or non-morular solid growth pattern. Grade 2 is 6 through 50% of a non squamous or non-morular solid growth pattern. Grade 3 is more than 50% of a non-squamous or non-morular solid growth pattern. Generally the higher the stage the worse the outcome.
LisaPizza's picture
LisaPizza
Posts: 208
Joined: Feb 2018

Oops, we were posting at the same time!

BluebirdOne's picture
BluebirdOne
Posts: 194
Joined: Jul 2018

Denise 

LisaPizza's picture
LisaPizza
Posts: 208
Joined: Feb 2018

Found it, don't know if table format will post well:

https://clinicaltrials.gov/ct2/show/results/NCT00942357

 

 The three columns are the chemoradiation arm, the chemo only arm, and total.

 

Endometrioid Grade 1

87
  23.5%
79
  21.6%
166
  22.6%

Endometrioid Grade 2

103
  27.8%
118
  32.2%
221
  30.0%

Endometrioid Grade 3

66
  17.8%
62
  16.9%
128
  17.4%

Serous

66
  17.8%
65
  17.8%
131
  17.8%

Clear Cell

10
   2.7%
12
   3.3%
22
   3.0%

Other

38
  10.3%
30
   8.2%
68
   9.2%
[1]

 

Measure Description: Grade 1 is 5% or less of a non-squamous or non-morular solid growth pattern. Grade 2 is 6 through 50% of a non squamous or non-morular solid growth pattern. Grade 3 is more than 50% of a non-squamous or non-morular solid growth pattern. Generally the higher the stage the worse the outcome.
zsazsa1
Posts: 311
Joined: Oct 2018

I still haven't been able to get at the full article from NEJM, but I think this is the report from the GOG-258.  I did take its preliminary results into account when I made my decision to have external beam pelvic after the chemo, because there were other studies that showed benefit to radiation.  Still, it's discouraging, because essentially what this study seems to say is that the die is cast before diagnosis.  If you have distant isolated cells or micrometastases beyond the field of radiation, that aren't killed by the chemo, that determines your outcome.

What they say about radiation possibly interfering with being able to complete chemo is true.  Had I done the "sandwich" protocol, I would not have been able to complete chemo afterwards, because of the serious decrease in hemoglobin, white count, and platelets that the radiation has caused.  In fact, I doubt I would have been able to tolerate chemo at all, if I'd had radiation done first.

The side effects from the chemo mostly are gone by a few weeks afterwards, except for the neuropathy that some of us have.  But I can tell you that 5 weeks after having finished external beam pelvic IMRT, although I don't have constant, intractible diarrhea any longer, I'm still bloated, still having a lot of GI discomfort, and some mild bladder discomfort, too.  Now, in light of the full results of the GOG-258, I don't know what I would advise someone newly diagnosed.  There have been studies that seemed to confirm the benefit of radiation (most recently, the PORTEC-3).

 

mamlicsw's picture
mamlicsw
Posts: 26
Joined: May 2019

Thanks so much for posting the article on radiation treatment for early stage high risk patients, which is what I am.  I just started chemotherapy yesterday and have begun thinking about radiation therapy when I complete the six cycles.  I plan to ask the both my medical oncologist and my radiaiton oncologist (when I meet with her) about this study.  I don't find many articles/studies about my specific category so this felt especially helpful.  Mary Ann

zsazsa1
Posts: 311
Joined: Oct 2018

Welcome, Mary Ann.  This was, for me, a very difficult decision, made after a ton of research and consulations.  I'm sending you a private message.

LisaPizza's picture
LisaPizza
Posts: 208
Joined: Feb 2018

"Still, it's discouraging, because essentially what this study seems to say is that the die is cast before diagnosis. If you have distant isolated cells or micrometastases beyond the field of radiation, that aren't killed by the chemo, that determines your outcome"

 

--- I think that's always been known to be true, for all types of cancer. Either adjuvant chemo kills those micromets or it doesn't. The problem is we don't know if it worked until a recurrence happens, or you die 20 years later from something else with no cancer recurrence."

 

"What they say about radiation possibly interfering with being able to complete chemo is true."

 

--- Agree. It would be interesting to know the recurrence and survival differences between just the subgroup that did actually receive the full planned course.

 

Even those who finished all treatments on time aren't directly comparable to many if us. For example, I had taxol/carbo (AUC6) x 6, followed by rads x 25. But the study group had concurrent cisplatin and radiation, followed by taxol/carbo (AUC 5 or 6) x 4 cycles instead of 6.

BluebirdOne's picture
BluebirdOne
Posts: 194
Joined: Jul 2018

I received four cycles of carboplatin and paclitaxel, with a sandwich of brachy between three and four.  I am not sure that this study had anything to do with it, as mostly they were concerned with neuropathy and my blood counts trending down. They never recommended full pelvic radiation. (I am stage 1a UPSC, with LVSI, her2 negative)  What I remember is they gave me an option to have no chemo, no radiation, just observation, or chemo, or chemo and radiation. After reading that having brachy would cut my vaginal recurrence rate to 6% I decided to go ahead. Each chemo is effective at a 20% rate, so having the two, especially the paclitaxel, was a risk I was willing to take. I had microscopic cells in the uterus. 

I find it so interesting that there are so many treatments, so many different outcomes, so many unknowns for the exact same stage and type. Since my brachy, I have read things that the sandwich treatment is good, or it is ineffective. Since the vagina is the most common non-peritoneal recurrence place I think the recommendation was a sound one for me. With all of us, only time will tell and we all know that what works for one won't work for another. 

MAbound
Posts: 847
Joined: Jun 2016

As time goes on I am feeling better and better about the treatment plan I was on for my stage 3a endometrial adenocarcinoma.

I had the full monty open abdomen radical hysterectomy. There have been some recent concerns raised about recurrence with robotic procedures that make me feel like the peace of mind I have now is worth the harder recovery and ginormous scar I have. 

I was concerned about not getting the "sandwich" treatment it seemed everyone else was, but my gyn oncologist's reasoning for not going with the trend just made so much sense to me that I settled down about it. This article just reinforces that maybe he really knew best and wasn't just going "old school" on me. I got through chemo without the difficulties some have had on the back end.

The decision to radiate or not was as big a deal for me as it has been for many. It seems like that experience repeats itself for each of us that face it.  The criteria for going through with it or not that Moekay shared with me at the time made such a difference in making that decision and feeling like I was doing the right thing in spite of the risks faced and new studies that come along afterward in articles like this. I still feel confident about having gone through with having radiation. In the right circumstances, when the risk of pelvic recurrence is higher, it's worth rolling the dice in spite of the odds for treatable consequences down the road. 

Studies like this don't hold a lot of water with me because there are flaws in them and unaccounted for variables. Studies like these should never be considered conclusive in themselves because numbers can be manipulated to say anything you want by picking and choosing data. I get more excited by data that gets replicated in multiple studies by unconnected researchers. This study only raises more questions than answers and really only points to a direction where more investigation is needed. It's more a survey of cherry-picked data than a study using scientific methodolgy. I'm not saying it's inaccurate or sloppy, but I'm not sure any of our doctor's would change their course of practice from just reading this.

MAbound
Posts: 847
Joined: Jun 2016

We all encounter articles like this as we research and I think it may be important to understand the difference between a scientific study and a survey to know which ones to get excited about versus which ones to just find interesting. Many times, surveys are presented to us by the media as if they are studies and the two are just not the same or interchangeable.

The difference is that scientific studies produce testable data whereas surveys gather available data and infer conclusions from them.

Both generally originate from a hypothesis a researcher has and wants to check out. Studies have more value because they can prove or disprove a hypothesis and lead to a theory that can then be replicated in other studies to become an indisputable fact. They can generate data or facts that can be relied on to be true whereas surveys cannot.

Surveys vary in their value based on how complete and unbiased the data used in them is. They are impacted by the motives behind them, how well the criteria for the survey is formulated, and the difficulty in covering all of the bases for formulating the survey and collecting the data. Sometimes what is trying to be surveyed is just too broad to be able to feasably collect the data needed to make useful inferences and the hypothesis needs to be reformulated to be more focused. Such surveys often just add to the noise and confusion out there. Conclusions made in surveys are never facts and shouldn't be taken to be. They are more indicators of directions for future research that someone may want to explore.

Every time you read an article or hear a story on the news, it helps to ask yourself if you are being given facts from a study vs. inferences from a survey and you'll have a better idea of how much weight to give it.

LisaPizza's picture
LisaPizza
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This study certainly had limits, but it was an interventional study, not a survey.

MAbound
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Foot in Mouth You are right, color me dumb for that mistake. After reading the two articles I didn't read the link to the actual study. Shame on me!

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LisaPizza
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No feet in mouth, we have our immune systems to consider!

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NoTimeForCancer
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agree wtih you, Lisa.  No need to think you stuck your foot in your mouth, Moe.  This was a lively thread and gave everyone lots to think about.  It is all good. 

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LisaPizza
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And all her thoughts on surveys, research quality, and how things get reported in the press are so true and a major pet peeve of mine also.

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Soup52
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Well I had clear cell stage 3C. I had 5 weeks of external radiation followed by 3 internal over the course of 3 weeks. I then completed 6 rounds of carbo/ taxol. I didn’t have difficulty completing the chemo. Was radiation fun, no and especially not fun with internal.My oncologist said from the beginning that he wanted to treat this aggressively. So far it has worked. Diagnosed August 2015. I still think this all goes to prove that we are all individuals and no two cases are exactly alike. Are ther after effectls, yes! So far I’ve been able to live with them. Currently, I’m worried about lymphodema, but won’t be evaluated for another week...

MAbound
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That's why I think this study/survey might be too broad for it's britches. How can it hope to make conclusive inferences when there are so many variables? It takes a lot of extrapolation because there's no way to collect enough data to account for all of the exceptions. It's not useless because it raises good food for thought, but I'm not sure it stands up with enough weight to alter how our doctors will be treating us. I agree with the doctor who said "there is a lot of information missing in this study, which makes it hard to know how to generalize results".

Cancer care is just to complicated for one-size-fits-all generalizations. Radiation therapy after chemo was what was best for me, but radiation first or in the middle of treatment was what was effective for others. Same goes for all the other kinds of treatments. It all depends on understanding those variables, so the more focused studies, while not so sweeping or treatment altering in their conclusions, are probably of more use when it comes to making the nitty gritty decisions for how to proceed for our individual circumstances.

Cancer treatment is still a puzzle with many missing pieces and it would be so nice if someone could just come up with a cure or prevention that works for all. It just isn't going to happen that way, though. Progress is going to keep happening in bits and pieces. We have it better than it was 10 years ago, but we'll miss out on the progress yet to happen.

Thanks for sharing the article, the posts they recieve in reaction are as interesting as the article itself! Wink There is always more to learn!

zsazsa1
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It would be nice to see this analysed by histology (tumor type), but they must have done that.

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LisaPizza
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I suppose the full study would have the details,  but the comment below implies it didn't make a difference:

Exploratory subgroup analyses failed to identify a subgroup of patients who may have benefited more from chemoradiotherapy than from chemotherapy alone.

 

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EZLiving66
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It's such a complicated disease with so many variables. I only had three chemos with no radiation and in September, I will (knock on wood) be four years NED from UPSC, either Stage II or III (no lymph nodes taken or pelvic wash done). When I asked about radiation my doctor said IF it returns, we'll use radiation then. Yet, I have seen women here with Grade 1, Stage I cancer die even though they went through chemo and radiation.

Although, I will say I have two things going for me - I take 2000 mg of Metformin every day AND I have never cut my chemo hair! Remember Sampson in the Bible who after Delilah cut off his source of strength, his hair, he was defeated by the Philistines. I think that my hair is protecting me from my cancer coming back! (Ok, I don't REALLY believe this, but there's a little part of me that says, "Don't cut your hair. Why take a chance, Eldri?) My hair is almost to my waist but I wear it in a curly ponytail on top of my head so it's not so hard to take care of.  LOL

Love,

Eldri (with the long white, curly hair)

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LisaPizza
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Love this! :)

MoeKay
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I thought some of you might be interested to know more about the adverse incident at MD Anderson which was the subject of BluebirdOne's first article above.  Here is a link to the follow-up article:

https://www.nbcnews.com/news/us-news/no-one-should-die-blood-transfusion-so-why-did-it-n1021506

Here is an excerpt from the article:

"In early December, a nurse at the University of Texas MD Anderson Cancer Center gave a 23-year-old leukemia patient a blood transfusion that, unbeknownst to the medical staff, had become contaminated with bacteria.

The patient’s blood pressure soon plummeted, but there’s no evidence anyone at the nation’s top-ranked cancer hospital was actively monitoring her vital signs in the crucial moments during and after the procedure, a federal investigation found. She died a little more than a day later.

The potentially preventable death drew a harsh rebuke from the Centers for Medicare and Medicaid Services, whose subsequent investigation, made public Monday, uncovered systemic safety lapses at the hospital. Nurses were not properly monitoring patients’ vital signs while administering blood transfusions, not only in the case of the patient who died, but also in 18 out of 33 other cases examined, the investigation found.

Since receiving the federal report this month, the hospital’s leaders have made changes to improve training for nurses and require hourly checks on patients during transfusions."

 

 

 

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LisaPizza
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I had seen this but wasn't sure if it was the same incident. My first thought when i read it was that this was surely the result of understaffing. Therefore, further nurse training, alone, is not going to solve the problem. 

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derMaus
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I agree, training alone isn't going to cure anything. My recent hospital stay was hellish, with some of the worst nurses I have ever had in my life...and on an oncology ward, at that! If I started going into the details my post would cover an entire page,but my take-away was that my hospital was horribly run and mismanaged. The majority of nurses were burnt out/acting out/ and/or unsuited for their chosen line of work. One example (there are others): I couldn't move my bowels. I was offered no options until, finally when I was in tears and had been in the bathroom for an hour, I was handed a pair of gloves and a packet of KY jelly. Self-extraction worked at that particular point (sorry for TMI) but there was still, ahem, unfinished business. Every time the doctor came in and nurse reported shift change, she told him I'd had a BM. I'd pipe up to say what had happened but she continued to repeat the fiction. Unfortunately the hardened stool was causing extreme muscle pain, racheting up my need for pain killers. Finally after 3 days, I asked my oncologist about it when he was on rounds. He popped a cork: they had charted that I was having regular BM's ! Finally he ordered maximum-strength laxitives and an enema, which resolved the issue. To add insult to injury, a nurse came in later to chastise me: she'd been reprimanded by the doc for incorrect charting, and it was all my fault because I'd lied to her and said I'd had a BM. Just rereading this brings it back to me, and it ain't good. I think the major issue is the 12-hour day, which seems to be endemic. No human being is productive after about 10 hours, if that, and the 8-hour workday was set for a reason. You could tell some of them had been decent professionals at one time but were just burnt out, and that's NOT the kind of thing that "training" can fix. And, yes, I've worked in the public sector my whole life and have had to respond to investigations, and "training" is always the standard answer. But, as Connie said, the idea that you wouldn't KNOW to check someone, as part of your education and training, is unfathomable to me. 

barnyardgal
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What an awful experience! I'm so sorry you had to go thru that.

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Forherself
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sounds like malpractice to me.   Giving treatment ( a glove and KY Jelly and instructions to self extract)  and not entering it in the chart is very serious.  That the nurse then felt threatening you was ok makes me agree that the management of the hospital is incompetent.  They are not monitoring their staff.  I would go higher up and report the chastisement by the nurse.   But I am that way.  I am an RN and would report this.   NOt acceptable.    I am so sorry to hear you had care like this on top of everything else.   

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ConnieSW
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i can't imagine not monitoring VS during a blood transfusion. I am horrified. 

MAbound
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Thanks MoeKay. It's quite a provacative article that gets me up on my soap box (sorry!) about how hospitals are the least safe place to be when you are seriously ill, but what other choice do we have? 

One's first inclination is to blame frontline caregivers who weren't practicing as they were taught to do in school, but if you understood the working conditions they have to contend with, it's hard to blame just them. All of the bureaucracy involved with health care is just as much a part of the problem as workers cutting corners to keep up with what's demanded of them. Hospitals and outside labs cut more corners than they should in the name of frugality, especially when they employ lesser qualified personnel to perform tasks that they are minimally educated or on-the-job trained for. It just makes my blood boil where they say patients bear some responsibility when they've been given instruction on what to look for while recieving a transfusion. What?!! When patients need to be relied on to assist in high risk care they aren't qualified to self-administer, it's a big, fat red flag that administration is not adequately staffing their hospital. Workers do the best they can, but this is when bad things happen.

My own experience for my hysterectomy is an example of how widespread substandard health care in a hospital setting is. I had very caring people doing the best they could, but I still developed a preventable complication and was needlessly exposed to another serious one while I was a patient because staffing is minimal and some tasks are delegated to inadequately trained assistants who don't appreciate the implications of not doing a job correctly. Computerization has not helped at all; it just consumes a lot of time and impedes needed hands-on care and regular professional patient evaluation.

Health care in this country is such a complicated, overly expensive mess that just seems to keep getting worse instead of better in spite of all of the discoveries and advances that get made. It makes me wish I had that magic wand I could wave to make a do-over of where it all went so wrong, but I'm not sure exactly when or where that happened. In any case, do whatever it takes to get out of a hospital as quick as you can whenever you have to go in. 

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Forherself
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in the Canadian, and British, and US medical systems as an RN.  You are receiving the best medical care in the world.  Sometimes we forget that perfection is not a human quality.   There will always be things that go wrong.   It is a tragedy that this mistake happened while giving a blood transfusion.  I don't know any of the details.   But millions of transfusions are given safely too.  

MAbound
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Joined: Jun 2016

For what medical care costs in this country you'd think we'd have the best in the world, but I can't find anything to back up that claim. We're in fact no where near the top.

https://ceoworld.biz/2018/02/14/the-top-25-countries-with-the-best-healthcare-systems-the-world-in-2017/ 

https://www.iflscience.com/health-and-medicine/where-is-your-country-global-ranking-nations-healthcare-systems/

Human error is one thing and on an individual, but habitual cutting of corners is another. It's the system as it currently exists that impels institutional practices that put patients at risk. The nurse Bobbi had is dishonest and shouldn't be practicing, but Bobbi has a big point about the 12 hour shifts and what's reasonable to expect of a person who works in such a physically, emotionally, and intellectually demanding job. 

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Forherself
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was not incompetent but not following nursing practice, and should be reported to management of the hospital, especially for coming in after and telling her she should not talk to her doctor about her care.   But your article is about health care systems.   And they like socialiazed systems.  The US has the highest obesity rate in the world, which causes us to have lower life expectancy.  Along with drug abuse.   My nephew is Canadian.   He called us and asked us if we could get him in to see a gastroenterologist in the US.  He had lost 12 lobs, had bloody diarrhea, both symptoms of bowel cancer.   He was told that they didn't know when a gastroenterologist would see him.  Specialists in BC don't have a public number.  Your name is sent to them by a referring doctor, and they call you when they can schedule.  It coudl be 3-4 months before they call. you to schedule.   If the article you referred to was talking about prompt healthcare delivered, the results would be different.  We did get him in to see the doc the following week, he had his colonoscopy and all is well.   Imagine waiting 4 months just to get an appointment.

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