Maintenence chemo for stage II

Hello Doctor,
My Mom was diagnosed with stage IIc clear cell in Novemeber and has 2 more chemo sessions left of carboplatin and taxol. Her gynocologist/oncologist told her last week that she was doing great, and believes everything was removed during surgery. But he said that there was a recent study that said taking taxol for an additional 12 months after her original 6 cycles was proven to have a lower recurrence rate. Is this a new trial/study? Is it for early stages I and II? For clear cell?
Do you know where I can find out some more information on this?Would radiation be something as well to look into?

Thanks in advance,

[Annekathryn Goodman, M.D.]

Hi There,
I have pasted the abstract below. this study has caused quite alot of controversy worldwide. i would say that the oncology world is divided on whether the addition of a year of extra chemotherapy truly makes a difference in survival or whether one just keeps a woman on an extra year of chemotherapy. I would defer to your mother's oncologist who has the best sense of what is going on in her particular cancer. Radiation is not a standard intervention for ovarian cancer.
take care

Gynecol Oncol. 2003 Mar;88(3):282-8.  
Phase II trial of single agent carboplatin followed by dose-intense paclitaxel, followed by maintenance paclitaxel therapy in stage IV ovarian, fallopian tube, and peritoneal cancers: a Southwest Oncology Group trial.

Markman M, Glass T, Smith HO, Hatch KD, Weiss GR, Taylor SA, Goodwin JW, Alberts DS.
Cleveland Clinic Foundation, Cleveland, OH 44195, USA. ***@****

OBJECTIVE: To improve the survival of women with stage IV epithelial ovarian cancer the Southwest Oncology Group conducted a phase II trial examining two novel treatment strategies: (a) modification of the chemotherapy regimen (carboplatin/paclitaxel) based on evidence of response during treatment and (b) "maintenance therapy," with the monthly administration of single agent paclitaxel (maximum 2 years). METHODS: Individuals with histologically documented stage IV ovarian, fallopian tube, or peritoneal cancers initially received a maximum of 3 courses of single agent carboplatin (AUC 6), with the decision to administer a subsequent course based on specific response criteria (i.e., declines in serum CA-125 or shrinkage of measurable mass lesions). This was followed by single agent paclitaxel (150 mg/m(2)), delivered every 2 weeks for a maximum of 6 courses, again based on evidence of continued response to the treatment program. Finally, in the absence of disease progression or unacceptable toxicity, patients received single agent paclitaxel (175 mg/m2) for a maximum of 24 monthly courses. The primary study end point was 2-year overall survival, which was to be compared to the survival of a previously published historical control population [stage IV ovarian cancer patients treated with a "standard" cisplatin/paclitaxel regimen (GOG 111; McGuire WP, N Eng E J Med 1996; 334:1)]. This analysis was employed to determine if this novel strategy was worthy of further clinical investigation in a controlled clinical trial. RESULTS: There were 53 patients entered this multicenter study, of whom 50 were evaluable for toxicity and 51 for survival. There were 2 treatment-related deaths. Grades 2 and 3 neutrotoxicity were observed in 18 and 4% of patients, respectively. There were no major treatment-related protocol violations. The overall 2-year survival was 48% (95% CI, 34-62%), compared to 60% for the historical control group. CONCLUSIONS: While this trial demonstrated the feasibility of delivering a treatment regimen requiring frequent alternations in therapy based on predetermined changes in objective parameters of response, further exploration of this specific management approach does not appear warranted in stage IV ovarian cancer, based on the survival outcome compared to a reasonably similar historical control population. As this trial demonstrates, the prospective determination of clinical end points in a phase II study (e.g., 2-year survival) that will lead to continued evaluation of a particular investigative strategy in a large-scale randomized trial can be an effective method to reduce the bias and uncertainty often associated with this complex decision process.

PMID: 12648576 [PubMed - indexed for MEDLINE]
Related LinksPilot study of outpatient paclitaxel, carboplatin and gemcitabine for advanced stage epithelial ovarian, peritoneal, and fallopian tube cancer. [Gynecol Oncol. 2004] PMID: 15350364 Phase 2 trial of carboplatin, paclitaxel, and irinotecan in ovarian, fallopian tube, and primary peritoneal cancers. [Gynecol Oncol. 2004] PMID: 14751157 Combination chemotherapy with carboplatin and docetaxel in the treatment of cancers of the ovary and fallopian tube and primary carcinoma of the peritoneum. [J Clin Oncol. 2001] PMID: 11283121 Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. [J Clin Oncol. 2003] PMID: 12829663 Phase III trial of standard-dose intravenous cisplatin plus paclitaxel versus moderately high-dose carboplatin followed by intravenous paclitaxel and intraperitoneal cisplatin in small-volume stage III ovarian carcinoma: an intergroup study of the Gynecologic Oncology Group, Southwestern Oncology Group, and Eastern Cooperative Oncology Group. [J Clin Oncol. 2001]