Phase III trial concluded that there is no benefit with maintenance paclitaxel to patients with EARL

lindaprocopio

(not sure what to make of this, but for those with EARLY STAGE OVC, this may be helpful. This just came out in May 2011:)

A Randomized Phase III Trial of IV Carboplatin and Paclitaxel × 3 Courses Followed by Observation Versus Weekly Maintenance Low-Dose Paclitaxel in Patients With Early-Stage Ovarian Carcinoma: A Gynecologic Oncology Group Study

(Gynecol Oncol. 2011 May 6;[Epub Ahead of Print], RS Mannel, MF Brady, EC Kohn, P Hanjani, M Hiura, R Lee, K DeGeest, DE Cohn, BJ Monk, H Michael)

This randomized phase III trial concluded that there is no benefit with maintenance paclitaxel to patients with early stage, high-risk ovarian cancer.

TAKE-HOME MESSAGE
This randomized phase III trial concluded that there is no benefit with maintenance paclitaxel to patients with early stage, high-risk ovarian cancer.

Abstract
Objective: To compare the recurrence-free interval (RFI) and safety profile in patients with completely resected high-risk early-stage ovarian cancer treated with intravenous (IV) carboplatin and paclitaxel with or without maintenance low-dose paclitaxel for 24 weeks.
Methods: Eligibility was limited to patients with stage IA/B (grade 3 or clear cell), all IC or II epithelial ovarian cancer. All patients were to receive carboplatin AUC 6 and paclitaxel 175 mg/m2 q3 weeks × 3 courses with random assignment to either observation or maintenance paclitaxel 40 mg/m2/week × 24 weeks. Recurrence required clinical or radiological evidence of new tumor.

Results: There were 571 patients enrolled onto this study, of whom 29 were deemed ineligible due to inappropriate stage or pathology, leaving 542 patients. At least 3 cycles of treatment were administered to 524/542 (97%) of patients, and among those assigned to maintenance paclitaxel, 80% completed the regimen. The incidence of grade 2 or worse peripheral neuropathy (15.5% vs. 6%), infection/fever (19.9% vs. 8.7%), and dermatologic events (70.8% vs. 52.1%) was higher on the maintenance regimen (p < 0.001). The cumulative probability of recurring within 5 years for the maintenance paclitaxel regimen is 20% vs. 23% for surveillance (hazard ratio 0.807; 95% CI: 0.565–1.15). The probability of surviving 5 years was 85.4% and 86.2%, respectively.

Conclusion: Maintenance paclitaxel at 40 mg/m2/week × 24 weeks added to standard dose AUC6 and paclitaxel 175 mg/m2 × 3 doses provides no significant increase in RFI.

http://www.sciencedirect.com/science/article/pii/S0090825811001880

carolenk

different cancers
Dear Linda

This research was set up to be very rigorous (p < 0.001) and it is important to know what is of benefit and what really isn't. The "early stage" OVCAs may even be a different disease altogether--not behaving like the "late stage" OVCA.

What wasn't tested was "quality of life" and its obvious that the non-maintenance group had a better quality of life, too.

thanks for posting,

Carolen

Hissy_Fitz

carolenk said:

different cancers
Dear Linda

This research was set up to be very rigorous (p < 0.001) and it is important to know what is of benefit and what really isn't. The "early stage" OVCAs may even be a different disease altogether--not behaving like the "late stage" OVCA.

What wasn't tested was "quality of life" and its obvious that the non-maintenance group had a better quality of life, too.

thanks for posting,

Carolen

I did the year of Taxol
I did the year of Taxol maintenance, at almost the same dose as first line chemo. I actually did super well on it. In fact, I begged my doctor for another year of Taxol.

I was the last patient he used Taxol maintenance on, even though his personal experience with it was encouraging. He went to Avastin after me. I don't know what he is using now, since Avastin is so hard to get approval for, it seems.

Maintenance or not is a very, very personal choice, and one that has no "right" or "wrong" , should or shouldn't. I would do it again, in a heartbeat, but that's just me. The one thing I didn't understand was the choice some women made based solely on "I want my hair back." That just seems like a pretty shallow reason, to me, to discount any type of treatment.

Carlene