Treatment options for muscle-invasive urothelial cancer for patients who were not eligible for cystectomy or neoadjuvant chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin: Report of Southwest Oncology Group Trial 8733

Celestia S. Higano, Catherine M. Tangen, Wael A. Sakr, James Faulkner, Saul E. Rivkin, Frederick J Meyers, Maha Hussain, Laurence H. Baker, Kenneth J. Russell, E. David Crawford, Connie Barnes

Research output: Contribution to journalArticle

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Abstract

BACKGROUND. Many patients with invasive urothelial cell cancer are poor candidates for cisplatin-based chemotherapy, and many are high risk for cystectomy. Southwest Oncology Group Trial 8733 was designed to address treatment for such patients. METHODS. Eligible patients had primary or recurrent muscle-invasive disease with transitional cell or squamous cell histology, a performance status from 0 to 2, no extrapelvic disease, a life expectancy >3 months, and adequate hematologic function. The treating clinician assigned patients to operable or inoperable groups. All patients received 2 cycles of 5-fluorouracil (5-FU) at a dose of 1000 mg/m2 per day x 4 starting concurrently with radiation at a dose of 200 centigrays per day x 10 each cycle. After 2 cycles, operable patients with positive biopsies underwent cystectomy, and patients with negative biopsies received a third cycle of chemoradiotherapy. Patients in the inoperable group received 3 cycles without interim biopsy. RESULTS. Eighteen of 24 eligible patients in the operable group were evaluable for response. Five patients had a complete response (CR), 9 patients had stable disease, 1 patient had progressive disease, and 3 patients were not assessable. The median progression-free survival was 10 months (95% confidence interval [95% CI] 4-14 months), and the median overall survival was 18 months (95% CI, 7-28 months). In the inoperable group, 35 of 37 eligible patients were evaluable for response with 17 CRs (49%; 95% CI, 31%-66%). The median progression-free survival was 13 months (95% CI, 10-17 months), and the median overall survival was 20 months (95% CI, 11-53 months). There were no episodes of grade 4 toxicity. CONCLUSIONS. In the current study, the combination of 5-FU and radiation was found to be tolerated well by patients with numerous comorbidities who could not tolerate cisplatin-based therapy or cystectomy.

Original languageEnglish (US)
Pages (from-to)2181-2187
Number of pages7
JournalCancer
Volume112
Issue number10
DOIs
StatePublished - May 15 2008

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Vinblastine
Cystectomy
Methotrexate
Doxorubicin
Cisplatin
Drug Therapy
Muscles
Neoplasms
Therapeutics
Confidence Intervals
Biopsy
Fluorouracil
Disease-Free Survival
Radiation
Survival
Chemoradiotherapy
Life Expectancy

Keywords

  • Bladder cancer
  • Bladder sparing
  • Continuous infusion 5-fluorouracil
  • Radiation
  • Urothelial cancer

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Treatment options for muscle-invasive urothelial cancer for patients who were not eligible for cystectomy or neoadjuvant chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin : Report of Southwest Oncology Group Trial 8733. / Higano, Celestia S.; Tangen, Catherine M.; Sakr, Wael A.; Faulkner, James; Rivkin, Saul E.; Meyers, Frederick J; Hussain, Maha; Baker, Laurence H.; Russell, Kenneth J.; Crawford, E. David; Barnes, Connie.

In: Cancer, Vol. 112, No. 10, 15.05.2008, p. 2181-2187.

Research output: Contribution to journalArticle

Higano, Celestia S. ; Tangen, Catherine M. ; Sakr, Wael A. ; Faulkner, James ; Rivkin, Saul E. ; Meyers, Frederick J ; Hussain, Maha ; Baker, Laurence H. ; Russell, Kenneth J. ; Crawford, E. David ; Barnes, Connie. / Treatment options for muscle-invasive urothelial cancer for patients who were not eligible for cystectomy or neoadjuvant chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin : Report of Southwest Oncology Group Trial 8733. In: Cancer. 2008 ; Vol. 112, No. 10. pp. 2181-2187.
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title = "Treatment options for muscle-invasive urothelial cancer for patients who were not eligible for cystectomy or neoadjuvant chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin: Report of Southwest Oncology Group Trial 8733",
abstract = "BACKGROUND. Many patients with invasive urothelial cell cancer are poor candidates for cisplatin-based chemotherapy, and many are high risk for cystectomy. Southwest Oncology Group Trial 8733 was designed to address treatment for such patients. METHODS. Eligible patients had primary or recurrent muscle-invasive disease with transitional cell or squamous cell histology, a performance status from 0 to 2, no extrapelvic disease, a life expectancy >3 months, and adequate hematologic function. The treating clinician assigned patients to operable or inoperable groups. All patients received 2 cycles of 5-fluorouracil (5-FU) at a dose of 1000 mg/m2 per day x 4 starting concurrently with radiation at a dose of 200 centigrays per day x 10 each cycle. After 2 cycles, operable patients with positive biopsies underwent cystectomy, and patients with negative biopsies received a third cycle of chemoradiotherapy. Patients in the inoperable group received 3 cycles without interim biopsy. RESULTS. Eighteen of 24 eligible patients in the operable group were evaluable for response. Five patients had a complete response (CR), 9 patients had stable disease, 1 patient had progressive disease, and 3 patients were not assessable. The median progression-free survival was 10 months (95{\%} confidence interval [95{\%} CI] 4-14 months), and the median overall survival was 18 months (95{\%} CI, 7-28 months). In the inoperable group, 35 of 37 eligible patients were evaluable for response with 17 CRs (49{\%}; 95{\%} CI, 31{\%}-66{\%}). The median progression-free survival was 13 months (95{\%} CI, 10-17 months), and the median overall survival was 20 months (95{\%} CI, 11-53 months). There were no episodes of grade 4 toxicity. CONCLUSIONS. In the current study, the combination of 5-FU and radiation was found to be tolerated well by patients with numerous comorbidities who could not tolerate cisplatin-based therapy or cystectomy.",
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author = "Higano, {Celestia S.} and Tangen, {Catherine M.} and Sakr, {Wael A.} and James Faulkner and Rivkin, {Saul E.} and Meyers, {Frederick J} and Maha Hussain and Baker, {Laurence H.} and Russell, {Kenneth J.} and Crawford, {E. David} and Connie Barnes",
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T1 - Treatment options for muscle-invasive urothelial cancer for patients who were not eligible for cystectomy or neoadjuvant chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin

T2 - Report of Southwest Oncology Group Trial 8733

AU - Higano, Celestia S.

AU - Tangen, Catherine M.

AU - Sakr, Wael A.

AU - Faulkner, James

AU - Rivkin, Saul E.

AU - Meyers, Frederick J

AU - Hussain, Maha

AU - Baker, Laurence H.

AU - Russell, Kenneth J.

AU - Crawford, E. David

AU - Barnes, Connie

PY - 2008/5/15

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N2 - BACKGROUND. Many patients with invasive urothelial cell cancer are poor candidates for cisplatin-based chemotherapy, and many are high risk for cystectomy. Southwest Oncology Group Trial 8733 was designed to address treatment for such patients. METHODS. Eligible patients had primary or recurrent muscle-invasive disease with transitional cell or squamous cell histology, a performance status from 0 to 2, no extrapelvic disease, a life expectancy >3 months, and adequate hematologic function. The treating clinician assigned patients to operable or inoperable groups. All patients received 2 cycles of 5-fluorouracil (5-FU) at a dose of 1000 mg/m2 per day x 4 starting concurrently with radiation at a dose of 200 centigrays per day x 10 each cycle. After 2 cycles, operable patients with positive biopsies underwent cystectomy, and patients with negative biopsies received a third cycle of chemoradiotherapy. Patients in the inoperable group received 3 cycles without interim biopsy. RESULTS. Eighteen of 24 eligible patients in the operable group were evaluable for response. Five patients had a complete response (CR), 9 patients had stable disease, 1 patient had progressive disease, and 3 patients were not assessable. The median progression-free survival was 10 months (95% confidence interval [95% CI] 4-14 months), and the median overall survival was 18 months (95% CI, 7-28 months). In the inoperable group, 35 of 37 eligible patients were evaluable for response with 17 CRs (49%; 95% CI, 31%-66%). The median progression-free survival was 13 months (95% CI, 10-17 months), and the median overall survival was 20 months (95% CI, 11-53 months). There were no episodes of grade 4 toxicity. CONCLUSIONS. In the current study, the combination of 5-FU and radiation was found to be tolerated well by patients with numerous comorbidities who could not tolerate cisplatin-based therapy or cystectomy.

AB - BACKGROUND. Many patients with invasive urothelial cell cancer are poor candidates for cisplatin-based chemotherapy, and many are high risk for cystectomy. Southwest Oncology Group Trial 8733 was designed to address treatment for such patients. METHODS. Eligible patients had primary or recurrent muscle-invasive disease with transitional cell or squamous cell histology, a performance status from 0 to 2, no extrapelvic disease, a life expectancy >3 months, and adequate hematologic function. The treating clinician assigned patients to operable or inoperable groups. All patients received 2 cycles of 5-fluorouracil (5-FU) at a dose of 1000 mg/m2 per day x 4 starting concurrently with radiation at a dose of 200 centigrays per day x 10 each cycle. After 2 cycles, operable patients with positive biopsies underwent cystectomy, and patients with negative biopsies received a third cycle of chemoradiotherapy. Patients in the inoperable group received 3 cycles without interim biopsy. RESULTS. Eighteen of 24 eligible patients in the operable group were evaluable for response. Five patients had a complete response (CR), 9 patients had stable disease, 1 patient had progressive disease, and 3 patients were not assessable. The median progression-free survival was 10 months (95% confidence interval [95% CI] 4-14 months), and the median overall survival was 18 months (95% CI, 7-28 months). In the inoperable group, 35 of 37 eligible patients were evaluable for response with 17 CRs (49%; 95% CI, 31%-66%). The median progression-free survival was 13 months (95% CI, 10-17 months), and the median overall survival was 20 months (95% CI, 11-53 months). There were no episodes of grade 4 toxicity. CONCLUSIONS. In the current study, the combination of 5-FU and radiation was found to be tolerated well by patients with numerous comorbidities who could not tolerate cisplatin-based therapy or cystectomy.

KW - Bladder cancer

KW - Bladder sparing

KW - Continuous infusion 5-fluorouracil

KW - Radiation

KW - Urothelial cancer

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