Two articles of interest
Comments
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Studies vs. Surveys
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.
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Well I had clear cell stage
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...
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This study certainly hadMAbound said:Studies vs. Surveys
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.
This study certainly had limits, but it was an interventional study, not a survey.
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Moe, I can't say. I have toMoeKay said:I don't buy reason for increased mortality
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.
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
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On the money
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!
There is always more to learn!0 -
Foot in MouthLisaPizza said:This study certainly had
This study certainly had limits, but it was an interventional study, not a survey.
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!0 -
agree wtih you, Lisa. NoLisaPizza said:No feet in mouth, we have our
No feet in mouth, we have our immune systems to consider!
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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Both right to a degreeMoeKay said:I don't buy reason for increased mortality
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.
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!
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Totally agree, MA. ThereMAbound said:Both right to a degree
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!
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?
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I can tell you that theNoTimeForCancer said:Totally agree, MA. There
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?
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.
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Questions Remainzsazsa1 said:I can tell you that the
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.
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.
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And all her thoughts onNoTimeForCancer said:agree wtih you, Lisa. No
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.
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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It's such a complicated
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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Love this!EZLiving66 said:It's such a complicated
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)
Love this!
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It would be nice to see thisMAbound said:On the money
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!
There is always more to learn!It would be nice to see this analysed by histology (tumor type), but they must have done that.
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FascinatingLisaPizza said:A more detailed article about
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, 2019Among 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, 2019All material on this website is protected by copyright, Copyright © 1994-2019 by WebMD LLC. This website also contains material copyrighted by 3rd parties.
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.
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I suppose the full studyzsazsa1 said:It would be nice to see this
It would be nice to see this analysed by histology (tumor type), but they must have done that.
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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GOG 258LisaPizza said:A more detailed article about
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, 2019Among 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, 2019All material on this website is protected by copyright, Copyright © 1994-2019 by WebMD LLC. This website also contains material copyrighted by 3rd parties.
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
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WOW!DebiR said:GOG 258
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
What an encouragement that is to hear! 5 years!!! Thank you for sharing!
0
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