Pilot phase II trial of radiation "sandwiched" between combination paclitaxel/platinum chemotherapy in patients with uterine papillary serous carcinoma (UPSC)

Abbie L. Fields, Mark H. Einstein, Akiva P. Novetsky, Juliana Gebb, Gary L. Goldberg

Research output: Contribution to journalArticle

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Abstract

Objectives.: To evaluate disease-free survival (DFS) and overall survival (OS) in patients treated with pelvic radiation "sandwiched" between six cycles of paclitaxel(T)/platinum(P) chemotherapy with optimally reduced uterine papillary serous carcinoma (UPSC). Methods.: Surgically staged patients with UPSC and no visible residual disease were enrolled. Treatment involved T (175 mg/m2) and either cisplatin (75 mg/m2) or carboplatin (AUC = 6.0, 6.5, 7.5) every 21 days × 3 doses, followed by pelvic RT (45 Gy). Fields were extended for > 2 positive pelvic or confirmed para-aortic node disease. Three additional cycles of T/P were administered after RT. Toxicity was graded by NCI CTC Version 3.0. Kaplan-Meier survival statistics were used for DFS/OS. Results.: 30 women were enrolled between 1999 and 2004. Median age was 69 years (45-82 years). 60% (18/30) of patients had disease confined to the uterus (Stage I/II) and 40% (12/30) had extra-uterine disease (Stage III/IV). 29 patients completed protocol treatment. One patient was discontinued due to non-compliance and recurred at 7 months. All 30 patients are included in survival analysis. Three-year DFS and OS with Stage I/II disease was 69% and 75% and Stage III/IV disease was 54% and 52%, respectively. Of 177 chemotherapy cycles administered, grade 3 or 4 neutropenia, thrombocytopenia or anemia occurred in 42%, 1% and 3% of cycles, respectively. Six cycles were delayed 1 week for neutropenia. 43% of all neutropenic episodes occurred after RT. Conclusion.: Radiation "sandwiched" between T/P chemotherapy is a well-tolerated and efficacious regimen for patients with completely resected UPSC. A larger multi-institutional clinical trial should be considered to confirm these pilot data.

Original languageEnglish (US)
Pages (from-to)201-206
Number of pages6
JournalGynecologic Oncology
Volume108
Issue number1
DOIs
StatePublished - Jan 2008

Fingerprint

Papillary Carcinoma
Paclitaxel
Platinum
Radiation
Drug Therapy
Disease-Free Survival
Survival
Neutropenia
Uterine Diseases
Aortic Diseases
Carboplatin
Survival Analysis
Clinical Protocols
Cisplatin
Uterus
Area Under Curve
Anemia
Clinical Trials

Keywords

  • Carboplatin
  • Paclitaxel
  • Radiation therapy
  • Uterine cancer
  • Uterine papillary serous carcinoma (UPSC)

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

Pilot phase II trial of radiation "sandwiched" between combination paclitaxel/platinum chemotherapy in patients with uterine papillary serous carcinoma (UPSC). / Fields, Abbie L.; Einstein, Mark H.; Novetsky, Akiva P.; Gebb, Juliana; Goldberg, Gary L.

In: Gynecologic Oncology, Vol. 108, No. 1, 01.2008, p. 201-206.

Research output: Contribution to journalArticle

Fields, Abbie L. ; Einstein, Mark H. ; Novetsky, Akiva P. ; Gebb, Juliana ; Goldberg, Gary L. / Pilot phase II trial of radiation "sandwiched" between combination paclitaxel/platinum chemotherapy in patients with uterine papillary serous carcinoma (UPSC). In: Gynecologic Oncology. 2008 ; Vol. 108, No. 1. pp. 201-206.
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AU - Gebb, Juliana

AU - Goldberg, Gary L.

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AB - Objectives.: To evaluate disease-free survival (DFS) and overall survival (OS) in patients treated with pelvic radiation "sandwiched" between six cycles of paclitaxel(T)/platinum(P) chemotherapy with optimally reduced uterine papillary serous carcinoma (UPSC). Methods.: Surgically staged patients with UPSC and no visible residual disease were enrolled. Treatment involved T (175 mg/m2) and either cisplatin (75 mg/m2) or carboplatin (AUC = 6.0, 6.5, 7.5) every 21 days × 3 doses, followed by pelvic RT (45 Gy). Fields were extended for > 2 positive pelvic or confirmed para-aortic node disease. Three additional cycles of T/P were administered after RT. Toxicity was graded by NCI CTC Version 3.0. Kaplan-Meier survival statistics were used for DFS/OS. Results.: 30 women were enrolled between 1999 and 2004. Median age was 69 years (45-82 years). 60% (18/30) of patients had disease confined to the uterus (Stage I/II) and 40% (12/30) had extra-uterine disease (Stage III/IV). 29 patients completed protocol treatment. One patient was discontinued due to non-compliance and recurred at 7 months. All 30 patients are included in survival analysis. Three-year DFS and OS with Stage I/II disease was 69% and 75% and Stage III/IV disease was 54% and 52%, respectively. Of 177 chemotherapy cycles administered, grade 3 or 4 neutropenia, thrombocytopenia or anemia occurred in 42%, 1% and 3% of cycles, respectively. Six cycles were delayed 1 week for neutropenia. 43% of all neutropenic episodes occurred after RT. Conclusion.: Radiation "sandwiched" between T/P chemotherapy is a well-tolerated and efficacious regimen for patients with completely resected UPSC. A larger multi-institutional clinical trial should be considered to confirm these pilot data.

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