For this reason, other ways of extending the disease-free interval and improving survival are under investigation. The study by Markman and colleagues focuses on consolidation therapy, which is treatment administered after a complete pathologic or clinical response. Whole abdominal radiation, intraperitoneal radioactive phosphorus (32P), and chemotherapy have been evaluated.
In this study, the Gynecologic Oncology Group and Southwest Oncology Group compared 3 versus 12 months of maintenance paclitaxel in patients who had a complete response to platinum/paclitaxel chemotherapy. Two arms were established: one giving paclitaxel 175 mg/m2 over 3 hours every 28 days for 3 cycles, and another extending this regimen to 12 cycles.
The median progression-free survival times were 21 and 28 months in the 3- and 12-month arms, respectively. P values for the adjusted Cox model analysis and unadjusted log-rank test were .0023 and .0035, respectively, with the 12-month arm having superior results. The Cox model-adjusted 3-cycle versus 12-cycle progression hazard ratio was estimated to be 2.31 (99% CI, 1.08–4.94). Because the protocol recommended early termination of the trial at a cutoff P value of .005, the trial was discontinued and all women were given the opportunity to receive 12 courses of paclitaxel.
Although these results are statistically significant, the 5-year survival and disease-free intervals are not available. Therefore, the role of consolidation chemotherapy with agents such as paclitaxel—which is not without side effects—needs further investigation before it can become the standard of care.
Clinical implications. I present the option of consolidation chemotherapy to all patients, encouraging them to participate in clinical trials of the therapy. If a trial is not available, I give the patient the option of receiving 12 cycles of paclitaxel off protocol or continued observation. I also discuss current data, including pros and cons, with the patient prior to initiating consolidation therapy.
Related Reading
- Sorbe B, Swedish-Norwegian Ovarian Cancer Study Group. Consolidation treatment of advanced (FIGO stage III) ovarian carcinoma in complete surgical remission after induction chemotherapy: a randomized, controlled, clinical trial comparing whole abdominal radiotherapy, chemotherapy, and no further treatment. Int J Gynecol Cancer. 2003;13:278-286.
- Varia MA, Stehman FB, Bundy BN, et al. Intraperitoneal radioactive phosphorus (P32) versus observation after negative second-look laparotomy for stage III ovarian carcinoma: a randomized trial of the Gynecologic Oncology Group. J Clin Oncol. 2003;21:2849–2855.