Phase II trial of adjuvant pelvic radiation "sandwiched" between combination paclitaxel and carboplatin in women with uterine papillary serous carcinoma

Mark H. Einstein, Marina Frimer, Dennis Yi-Shin Kuo, Laura L. Reimers, Keyur J. Mehta, Subhakar Mutyala, Gloria S. Huang, June Y. Hou, Gary L. Goldberg

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Abstract

Objective: To evaluate the safety and survival in women treated with adjuvant pelvic radiation "sandwiched" between six cycles of paclitaxel and carboplatin chemotherapy with completely resected UPSC. Methods: Surgically staged women with UPSC (FIGO stage 1-4) and no visible residual disease were enrolled. Treatment involved paclitaxel (175 mg/m 2) and carboplatin (AUC = 6.0-7.5) every 21 days for 3 doses, followed by radiation therapy (RT), followed by an additional 3 cycles of paclitaxel and carboplatin (AUC = 5-6). Survival analysis, using Kaplan-Meier methods, was performed on patients who completed at least 3 cycles of chemotherapy and RT. Results: A total of 81 patients were enrolled, of which 72 patients completed the first 3 cycles of chemotherapy followed by prescribed RT. Median age was 67 years (range: 43-82 years). 59/72 (82%) had disease confined to the uterus and 13/72 (18%) had completely resected extra-uterine disease (stage 3 and 4). 65 (83%) completed the protocol. Overall PFS and OS for combined stage 1 and 2 patients was 65.5 ± 3.6 months and 76.5 ± 4.3 months, respectively. PFS and OS for combined stage 3 and 4 patients was 25.8 ± 3.0 and 35.9 ± 5.3 months, respectively. Three-year % survival probability for stage 1 and 2 patients was 84% and for stage 3 and 4 patients was 50%. Of the 435 chemotherapy cycles administered, there were 11(2.5%) G3/G4 non-hematologic toxicities. 26(6.0%) cycles had dose reductions and 37(8.5%) had dose delays. Conclusions: Compared to prior studies of single modality adjuvant therapy, RT "sandwiched" between paclitaxel and carboplatin chemotherapy is well-tolerated and highly efficacious in women with completely resected UPSC.

Original languageEnglish (US)
Pages (from-to)21-25
Number of pages5
JournalGynecologic Oncology
Volume124
Issue number1
DOIs
StatePublished - Jan 2012

Fingerprint

Papillary Carcinoma
Carboplatin
Paclitaxel
Radiation
Drug Therapy
Radiotherapy
Area Under Curve
Uterine Diseases
Survival
Survival Analysis
Uterus
Safety
Therapeutics

Keywords

  • Adjuvant treatment
  • Chemotherapy
  • Phase II trial
  • Radiation therapy
  • UPSC
  • Uterine cancer

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

Phase II trial of adjuvant pelvic radiation "sandwiched" between combination paclitaxel and carboplatin in women with uterine papillary serous carcinoma. / Einstein, Mark H.; Frimer, Marina; Kuo, Dennis Yi-Shin; Reimers, Laura L.; Mehta, Keyur J.; Mutyala, Subhakar; Huang, Gloria S.; Hou, June Y.; Goldberg, Gary L.

In: Gynecologic Oncology, Vol. 124, No. 1, 01.2012, p. 21-25.

Research output: Contribution to journalArticle

Einstein, Mark H. ; Frimer, Marina ; Kuo, Dennis Yi-Shin ; Reimers, Laura L. ; Mehta, Keyur J. ; Mutyala, Subhakar ; Huang, Gloria S. ; Hou, June Y. ; Goldberg, Gary L. / Phase II trial of adjuvant pelvic radiation "sandwiched" between combination paclitaxel and carboplatin in women with uterine papillary serous carcinoma. In: Gynecologic Oncology. 2012 ; Vol. 124, No. 1. pp. 21-25.
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abstract = "Objective: To evaluate the safety and survival in women treated with adjuvant pelvic radiation {"}sandwiched{"} between six cycles of paclitaxel and carboplatin chemotherapy with completely resected UPSC. Methods: Surgically staged women with UPSC (FIGO stage 1-4) and no visible residual disease were enrolled. Treatment involved paclitaxel (175 mg/m 2) and carboplatin (AUC = 6.0-7.5) every 21 days for 3 doses, followed by radiation therapy (RT), followed by an additional 3 cycles of paclitaxel and carboplatin (AUC = 5-6). Survival analysis, using Kaplan-Meier methods, was performed on patients who completed at least 3 cycles of chemotherapy and RT. Results: A total of 81 patients were enrolled, of which 72 patients completed the first 3 cycles of chemotherapy followed by prescribed RT. Median age was 67 years (range: 43-82 years). 59/72 (82{\%}) had disease confined to the uterus and 13/72 (18{\%}) had completely resected extra-uterine disease (stage 3 and 4). 65 (83{\%}) completed the protocol. Overall PFS and OS for combined stage 1 and 2 patients was 65.5 ± 3.6 months and 76.5 ± 4.3 months, respectively. PFS and OS for combined stage 3 and 4 patients was 25.8 ± 3.0 and 35.9 ± 5.3 months, respectively. Three-year {\%} survival probability for stage 1 and 2 patients was 84{\%} and for stage 3 and 4 patients was 50{\%}. Of the 435 chemotherapy cycles administered, there were 11(2.5{\%}) G3/G4 non-hematologic toxicities. 26(6.0{\%}) cycles had dose reductions and 37(8.5{\%}) had dose delays. Conclusions: Compared to prior studies of single modality adjuvant therapy, RT {"}sandwiched{"} between paclitaxel and carboplatin chemotherapy is well-tolerated and highly efficacious in women with completely resected UPSC.",
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T1 - Phase II trial of adjuvant pelvic radiation "sandwiched" between combination paclitaxel and carboplatin in women with uterine papillary serous carcinoma

AU - Einstein, Mark H.

AU - Frimer, Marina

AU - Kuo, Dennis Yi-Shin

AU - Reimers, Laura L.

AU - Mehta, Keyur J.

AU - Mutyala, Subhakar

AU - Huang, Gloria S.

AU - Hou, June Y.

AU - Goldberg, Gary L.

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N2 - Objective: To evaluate the safety and survival in women treated with adjuvant pelvic radiation "sandwiched" between six cycles of paclitaxel and carboplatin chemotherapy with completely resected UPSC. Methods: Surgically staged women with UPSC (FIGO stage 1-4) and no visible residual disease were enrolled. Treatment involved paclitaxel (175 mg/m 2) and carboplatin (AUC = 6.0-7.5) every 21 days for 3 doses, followed by radiation therapy (RT), followed by an additional 3 cycles of paclitaxel and carboplatin (AUC = 5-6). Survival analysis, using Kaplan-Meier methods, was performed on patients who completed at least 3 cycles of chemotherapy and RT. Results: A total of 81 patients were enrolled, of which 72 patients completed the first 3 cycles of chemotherapy followed by prescribed RT. Median age was 67 years (range: 43-82 years). 59/72 (82%) had disease confined to the uterus and 13/72 (18%) had completely resected extra-uterine disease (stage 3 and 4). 65 (83%) completed the protocol. Overall PFS and OS for combined stage 1 and 2 patients was 65.5 ± 3.6 months and 76.5 ± 4.3 months, respectively. PFS and OS for combined stage 3 and 4 patients was 25.8 ± 3.0 and 35.9 ± 5.3 months, respectively. Three-year % survival probability for stage 1 and 2 patients was 84% and for stage 3 and 4 patients was 50%. Of the 435 chemotherapy cycles administered, there were 11(2.5%) G3/G4 non-hematologic toxicities. 26(6.0%) cycles had dose reductions and 37(8.5%) had dose delays. Conclusions: Compared to prior studies of single modality adjuvant therapy, RT "sandwiched" between paclitaxel and carboplatin chemotherapy is well-tolerated and highly efficacious in women with completely resected UPSC.

AB - Objective: To evaluate the safety and survival in women treated with adjuvant pelvic radiation "sandwiched" between six cycles of paclitaxel and carboplatin chemotherapy with completely resected UPSC. Methods: Surgically staged women with UPSC (FIGO stage 1-4) and no visible residual disease were enrolled. Treatment involved paclitaxel (175 mg/m 2) and carboplatin (AUC = 6.0-7.5) every 21 days for 3 doses, followed by radiation therapy (RT), followed by an additional 3 cycles of paclitaxel and carboplatin (AUC = 5-6). Survival analysis, using Kaplan-Meier methods, was performed on patients who completed at least 3 cycles of chemotherapy and RT. Results: A total of 81 patients were enrolled, of which 72 patients completed the first 3 cycles of chemotherapy followed by prescribed RT. Median age was 67 years (range: 43-82 years). 59/72 (82%) had disease confined to the uterus and 13/72 (18%) had completely resected extra-uterine disease (stage 3 and 4). 65 (83%) completed the protocol. Overall PFS and OS for combined stage 1 and 2 patients was 65.5 ± 3.6 months and 76.5 ± 4.3 months, respectively. PFS and OS for combined stage 3 and 4 patients was 25.8 ± 3.0 and 35.9 ± 5.3 months, respectively. Three-year % survival probability for stage 1 and 2 patients was 84% and for stage 3 and 4 patients was 50%. Of the 435 chemotherapy cycles administered, there were 11(2.5%) G3/G4 non-hematologic toxicities. 26(6.0%) cycles had dose reductions and 37(8.5%) had dose delays. Conclusions: Compared to prior studies of single modality adjuvant therapy, RT "sandwiched" between paclitaxel and carboplatin chemotherapy is well-tolerated and highly efficacious in women with completely resected UPSC.

KW - Adjuvant treatment

KW - Chemotherapy

KW - Phase II trial

KW - Radiation therapy

KW - UPSC

KW - Uterine cancer

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