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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

Obermair, Andreas, Mileshkin, Linda, Merollini, Katharina, Kondalsamy-Chennakesavan, Srinivas, Cheuk, Robyn, Vasey, Paul, Wyld, David, Goh, Jeffrey, Nicklin, James L., Perrin, Lewis C., Sykes, Peter, & Janda, Monika (2010) Prospective, non-randomized phase 2 clinical trial of carboplatin plus paclitaxel with sequential radical pelvic radiotherapy for uterine papillary serous carcinoma. Gynecologic Oncology, 120(2), pp. 179-184.

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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.

Impact and interest:

7 citations in Scopus
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6 citations in Web of Science®

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ID Code: 39535
Item Type: Journal Article
Additional Information: The maiden name of Katharina Merollini is Katharina Bolz
Keywords: Uterine Papillary Serous Carcinoma, Carboplatin, Paclitaxel, Radiotherapy, Feasibility
DOI: 10.1016/j.ygyno.2010.10.039
ISSN: 0090-8258
Subjects: Australian and New Zealand Standard Research Classification > MEDICAL AND HEALTH SCIENCES (110000) > PUBLIC HEALTH AND HEALTH SERVICES (111700)
Divisions: Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Current > Schools > School of Public Health & Social Work
Copyright Owner: Copyright 2010 Elsevier Inc.
Deposited On: 20 Jan 2011 08:22
Last Modified: 15 Jul 2014 12:51

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