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

lindaprocopio
lindaprocopio CSN Member Posts: 1,980 Member
in Ovarian Cancer #1
(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.

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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

Comments

  • carolenk
    carolenk CSN Member Posts: 907 Member
    #2
    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
    Hissy_Fitz CSN Member Posts: 1,834 Member
    #3
    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

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