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Prospective, non-randomized phase 2 clinical trial of carboplatin plus paclitaxel with sequential radical pelvic radiotherapy for uterine papillary serous carcinoma

2010; Elsevier BV; Volume: 120; Issue: 2 Linguagem: Inglês

10.1016/j.ygyno.2010.10.039

1095-6859

Andreas Obermair, Linda Mileshkin, Katharina Bolz, Srinivas Kondalsamy‐Chennakesavan, Robyn Cheuk, P. Vasey, David Wyld, Jeffrey C. Goh, James Nicklin, Lewis Perrin, Peter Sykes, Monika Janda,

Cervical Cancer and HPV Research

ObjectiveUterine Papillary Serous Carcinoma (UPSC) is uncommon and accounts for less than 5% of all uterine cancers.Therefore the majority of evidence about the benefits of adjuvant treatment comes from retrospective case series.We conducted a prospective multi-centre non-randomized phase 2 clinical trial using four cycles of adjuvant paclitaxel plus carboplatin chemotherapy followed by pelvic radiotherapy, in order to evaluate the tolerability and safety of this approach. MethodsThis trial enrolled patients with newly diagnosed, previously untreated patients with stage 1b-4 (FIGO-1988) UPSC with a serous-papillary component of at least 30%.Paclitaxel (175 mg/m 2 ) and carboplatin (AUC 6) were administered on day 1 of each 3-week cycle for 4 cycles.Chemotherapy was followed by external beam radiotherapy to the whole pelvis (50.4 Gy over 5.5 weeks).Completion and toxicity of treatment (Common Toxicity Criteria, CTC) and quality of life measures were the primary outcome indicators. ResultsTwenty-nine of 31 patients completed treatment as planned.Dose reduction was needed in 9 patients (29%), treatment delay in 7 (23%), and treatment cessation in 2 patients (6.5%).Hematologic toxicity, grade 3 or 4 occurred in 19% (6/31) of patients.Patients' self-reported quality of life remained stable throughout treatment.Thirteen of the 29 patients with stage 1-3 disease (44.8%) recurred (average follow-up 28.1 months, range 8-60 months). ConclusionThis multimodal treatment is feasible, safe and tolerated reasonably well and would be suitable for use in multi-institutional prospective randomized clinical trials incorporating novel therapies in patients with UPSC.