A phase II evaluation of weekly gemcitabine and docetaxel for second-line treatment of recurrent carcinosarcoma of the uterus: A gynecologic oncology group study

Brigitte E. Miller, John A. Blessing, Frederick B. Stehman, Mark S. Shahin, S. Diane Yamada, Angeles Alvarez Secord, David P. Warshal, Ovadia Abulafia, William E. Richards, Linda Van Le

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Abstract

Background. The objective of this study was to estimate antitumor activity and toxicity of weekly docetaxel and gemcitabine as second-line chemotherapy for patients with recurrent uterine carcinosarcoma. Methods. Patients with recurrent carcinosarcoma of the uterus who had failed one regimen of chemotherapy, had a Gynecologic Oncology Group (GOG) performance status of 0-2 and had measurable disease were included. Treatment consisted of gemcitabine 600 mg/m2 and docetaxel 35 mg/m2 intravenously on days 1, 8 and 15 of a 28-day cycle until disease progression or intolerable adverse effects. This study employed an optimal but flexible two-stage design with an early stopping rule. If more than 3 out of 22-24 or more than 4 out of 25-29 patients responded, accrual to the second stage was to be initiated. Results. Twenty-eight patients were enlisted. Three patients were not eligible after pathology review. One patient was never treated. Twenty-four patients were evaluable. Nine patients had previous radiation therapy. There were no complete responses. Partial responses were seen in two patients (8.3%), stable disease in eight (33.3%) and progressive disease in 12 patients (50%). Two patients were not evaluable (8.3%). The median progression-free survival was 1.8 months. The median survival was 4.9 months. The treatment caused myelosuppression, mainly neutropenia, but also thrombocytopenia and anemia. Dose modifications became necessary in the majority of patients. In five patients, treatment was discontinued due to toxicity. Conclusions. This regimen of docetaxel and gemcitabine is not active in patients with recurrent carcinosarcoma of the uterus as second-line chemotherapy.

Original languageEnglish (US)
Pages (from-to)139-144
Number of pages6
JournalGynecologic Oncology
Volume118
Issue number2
DOIs
StatePublished - Aug 1 2010

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docetaxel
gemcitabine
Carcinosarcoma
Uterus
Therapeutics
Drug Therapy

Keywords

  • Carcinosarcoma
  • Docetaxel
  • Gemcitabine

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

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A phase II evaluation of weekly gemcitabine and docetaxel for second-line treatment of recurrent carcinosarcoma of the uterus : A gynecologic oncology group study. / Miller, Brigitte E.; Blessing, John A.; Stehman, Frederick B.; Shahin, Mark S.; Yamada, S. Diane; Secord, Angeles Alvarez; Warshal, David P.; Abulafia, Ovadia; Richards, William E.; Van Le, Linda.

In: Gynecologic Oncology, Vol. 118, No. 2, 01.08.2010, p. 139-144.

Research output: Contribution to journalArticle

Miller, Brigitte E. ; Blessing, John A. ; Stehman, Frederick B. ; Shahin, Mark S. ; Yamada, S. Diane ; Secord, Angeles Alvarez ; Warshal, David P. ; Abulafia, Ovadia ; Richards, William E. ; Van Le, Linda. / A phase II evaluation of weekly gemcitabine and docetaxel for second-line treatment of recurrent carcinosarcoma of the uterus : A gynecologic oncology group study. In: Gynecologic Oncology. 2010 ; Vol. 118, No. 2. pp. 139-144.
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abstract = "Background. The objective of this study was to estimate antitumor activity and toxicity of weekly docetaxel and gemcitabine as second-line chemotherapy for patients with recurrent uterine carcinosarcoma. Methods. Patients with recurrent carcinosarcoma of the uterus who had failed one regimen of chemotherapy, had a Gynecologic Oncology Group (GOG) performance status of 0-2 and had measurable disease were included. Treatment consisted of gemcitabine 600 mg/m2 and docetaxel 35 mg/m2 intravenously on days 1, 8 and 15 of a 28-day cycle until disease progression or intolerable adverse effects. This study employed an optimal but flexible two-stage design with an early stopping rule. If more than 3 out of 22-24 or more than 4 out of 25-29 patients responded, accrual to the second stage was to be initiated. Results. Twenty-eight patients were enlisted. Three patients were not eligible after pathology review. One patient was never treated. Twenty-four patients were evaluable. Nine patients had previous radiation therapy. There were no complete responses. Partial responses were seen in two patients (8.3{\%}), stable disease in eight (33.3{\%}) and progressive disease in 12 patients (50{\%}). Two patients were not evaluable (8.3{\%}). The median progression-free survival was 1.8 months. The median survival was 4.9 months. The treatment caused myelosuppression, mainly neutropenia, but also thrombocytopenia and anemia. Dose modifications became necessary in the majority of patients. In five patients, treatment was discontinued due to toxicity. Conclusions. This regimen of docetaxel and gemcitabine is not active in patients with recurrent carcinosarcoma of the uterus as second-line chemotherapy.",
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T1 - A phase II evaluation of weekly gemcitabine and docetaxel for second-line treatment of recurrent carcinosarcoma of the uterus

T2 - A gynecologic oncology group study

AU - Miller, Brigitte E.

AU - Blessing, John A.

AU - Stehman, Frederick B.

AU - Shahin, Mark S.

AU - Yamada, S. Diane

AU - Secord, Angeles Alvarez

AU - Warshal, David P.

AU - Abulafia, Ovadia

AU - Richards, William E.

AU - Van Le, Linda

PY - 2010/8/1

Y1 - 2010/8/1

N2 - Background. The objective of this study was to estimate antitumor activity and toxicity of weekly docetaxel and gemcitabine as second-line chemotherapy for patients with recurrent uterine carcinosarcoma. Methods. Patients with recurrent carcinosarcoma of the uterus who had failed one regimen of chemotherapy, had a Gynecologic Oncology Group (GOG) performance status of 0-2 and had measurable disease were included. Treatment consisted of gemcitabine 600 mg/m2 and docetaxel 35 mg/m2 intravenously on days 1, 8 and 15 of a 28-day cycle until disease progression or intolerable adverse effects. This study employed an optimal but flexible two-stage design with an early stopping rule. If more than 3 out of 22-24 or more than 4 out of 25-29 patients responded, accrual to the second stage was to be initiated. Results. Twenty-eight patients were enlisted. Three patients were not eligible after pathology review. One patient was never treated. Twenty-four patients were evaluable. Nine patients had previous radiation therapy. There were no complete responses. Partial responses were seen in two patients (8.3%), stable disease in eight (33.3%) and progressive disease in 12 patients (50%). Two patients were not evaluable (8.3%). The median progression-free survival was 1.8 months. The median survival was 4.9 months. The treatment caused myelosuppression, mainly neutropenia, but also thrombocytopenia and anemia. Dose modifications became necessary in the majority of patients. In five patients, treatment was discontinued due to toxicity. Conclusions. This regimen of docetaxel and gemcitabine is not active in patients with recurrent carcinosarcoma of the uterus as second-line chemotherapy.

AB - Background. The objective of this study was to estimate antitumor activity and toxicity of weekly docetaxel and gemcitabine as second-line chemotherapy for patients with recurrent uterine carcinosarcoma. Methods. Patients with recurrent carcinosarcoma of the uterus who had failed one regimen of chemotherapy, had a Gynecologic Oncology Group (GOG) performance status of 0-2 and had measurable disease were included. Treatment consisted of gemcitabine 600 mg/m2 and docetaxel 35 mg/m2 intravenously on days 1, 8 and 15 of a 28-day cycle until disease progression or intolerable adverse effects. This study employed an optimal but flexible two-stage design with an early stopping rule. If more than 3 out of 22-24 or more than 4 out of 25-29 patients responded, accrual to the second stage was to be initiated. Results. Twenty-eight patients were enlisted. Three patients were not eligible after pathology review. One patient was never treated. Twenty-four patients were evaluable. Nine patients had previous radiation therapy. There were no complete responses. Partial responses were seen in two patients (8.3%), stable disease in eight (33.3%) and progressive disease in 12 patients (50%). Two patients were not evaluable (8.3%). The median progression-free survival was 1.8 months. The median survival was 4.9 months. The treatment caused myelosuppression, mainly neutropenia, but also thrombocytopenia and anemia. Dose modifications became necessary in the majority of patients. In five patients, treatment was discontinued due to toxicity. Conclusions. This regimen of docetaxel and gemcitabine is not active in patients with recurrent carcinosarcoma of the uterus as second-line chemotherapy.

KW - Carcinosarcoma

KW - Docetaxel

KW - Gemcitabine

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