Journal article
Prospective, non-randomized phase 2 clinical trial of carboplatin plus paclitaxel with sequential radical pelvic radiotherapy for uterine papillary serous carcinoma
Gynecologic Oncology, Vol.120(2), pp.179-184
2011
Abstract
Objective: Uterine 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. Methods: This trial enrolled patients with newly diagnosed, previously untreated patients with stage 1b-4 (FIGO-1988) UPSC with a papillary serous component of at least 30%. Paclitaxel (175 mg/m2) 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. Results: Twenty-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 stages 1-3 disease (44.8%) recurred (average follow-up 28.1 months, range 8-60 months). Conclusion: This 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. © 2010 Elsevier Inc. All rights reserved.
Details
- Title
- Prospective, non-randomized phase 2 clinical trial of carboplatin plus paclitaxel with sequential radical pelvic radiotherapy for uterine papillary serous carcinoma
- Authors
- A Obermair (Author) - University of QueenslandL Mileshkin (Author) - Peter MacCallum Cancer CentreKatharina Bolz (Author) - University of QueenslandS Kondalsamy-Chennakesavan (Author) - University of QueenslandR Cheuk (Author) - Royal Brisbane and Women's HospitalP Vasey (Author) - Royal Brisbane and Women's HospitalD Wyld (Author) - Royal Brisbane and Women's HospitalJ Goh (Author) - Royal Brisbane and Women's HospitalJ L Nicklin (Author) - Royal Brisbane and Women's HospitalL C Perrin (Author) - Mater HospitalP Sykes (Author) - University of Otago, New ZealandM Janda (Author) - Queensland University of Technology
- Publication details
- Gynecologic Oncology, Vol.120(2), pp.179-184
- Publisher
- Academic Press
- Date published
- 2011
- DOI
- 10.1016/j.ygyno.2010.10.039
- ISSN
- 0090-8258
- Organisation Unit
- University of the Sunshine Coast, Queensland; School of Health and Sport Sciences - Legacy; School of Health and Behavioural Sciences - Legacy; School of Health - Public Health
- Language
- English
- Record Identifier
- 99451197502621
- Output Type
- Journal article
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