Phase II trial of paclitaxel/cisplatin followed by surgery and adjuvant radiation therapy and 5-fluorouracil/leucovorin for gastric cancer (ECOG E7296)

A. Bapsi Chakravarthy*, Paul J. Catalano, Joshua K. Mondschein, David I. Rosenthal, Daniel G. Haller, Richard Whittington, Francis R. Spitz, Henry Wagner, Elin R. Sigurdson, Loren K. Tschetter, Gerald K. Bayer, Mary Frances Mulcahy, Al B Benson III

*Corresponding author for this work

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

BACKGROUND: Randomized trials have shown an increase in survival with perioperative chemotherapy as well as with postoperative chemoradiation. It was hypothesized that combining induction chemotherapy with postoperative chemoradiation would be well tolerated and improve pathologic complete response. METHODS: Patients with resectable cancers of the stomach/gastroesophageal junction were eligible. Neoadjuvant chemotherapy consisted of 3 cycles of paclitaxel and cisplatin. Adjuvant therapy consisted of 1 cycle of 5-fluorouracil (FU) and leucovorin (LV) followed by chemoradiation (45 Gy with concurrent 5-FU/LV). Chemoradiation was followed by 2 additional cycles of 5-FU/LV. Response to neoadjuvant therapy was based on pathology. RESULTS: From 1999 to 2002, 38 eligible patients were enrolled; 35 completed induction chemotherapy, and 29 went on to surgery. Sixteen patients did not develop metastatic progression, 10 developed metastatic disease, and 12 were unevaluable. There were no pathologic complete responses after induction therapy. Twenty-five of 38 patients suffered grade 3-4 toxicities during induction paclitaxel/cisplatin. Six of the 7 patients who received postoperative therapy suffered grade 3-4 toxicities. Only 3 of 38 (7.9%) eligible patients completed all assigned treatment. The median overall survival was 1.6 years, and the 2-year survival was 40%. CONCLUSIONS: This regimen of neoadjuvant paclitaxel/cisplatin followed by postoperative 5-FU/LV-based chemoradiation did not have a high enough response rate and proved to be too toxic for further development.

Original languageEnglish (US)
Pages (from-to)191-197
Number of pages7
JournalGastrointestinal Cancer Research
Volume5
Issue number6
StatePublished - Nov 1 2013

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Leucovorin
Fluorouracil
Stomach Neoplasms
Radiotherapy
Induction Chemotherapy
Survival
Drug Therapy
Esophagogastric Junction
Neoadjuvant Therapy
Poisons
Therapeutics
TP protocol
Pathology

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology

Cite this

Bapsi Chakravarthy, A. ; Catalano, Paul J. ; Mondschein, Joshua K. ; Rosenthal, David I. ; Haller, Daniel G. ; Whittington, Richard ; Spitz, Francis R. ; Wagner, Henry ; Sigurdson, Elin R. ; Tschetter, Loren K. ; Bayer, Gerald K. ; Mulcahy, Mary Frances ; Benson III, Al B. / Phase II trial of paclitaxel/cisplatin followed by surgery and adjuvant radiation therapy and 5-fluorouracil/leucovorin for gastric cancer (ECOG E7296). In: Gastrointestinal Cancer Research. 2013 ; Vol. 5, No. 6. pp. 191-197.
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title = "Phase II trial of paclitaxel/cisplatin followed by surgery and adjuvant radiation therapy and 5-fluorouracil/leucovorin for gastric cancer (ECOG E7296)",
abstract = "BACKGROUND: Randomized trials have shown an increase in survival with perioperative chemotherapy as well as with postoperative chemoradiation. It was hypothesized that combining induction chemotherapy with postoperative chemoradiation would be well tolerated and improve pathologic complete response. METHODS: Patients with resectable cancers of the stomach/gastroesophageal junction were eligible. Neoadjuvant chemotherapy consisted of 3 cycles of paclitaxel and cisplatin. Adjuvant therapy consisted of 1 cycle of 5-fluorouracil (FU) and leucovorin (LV) followed by chemoradiation (45 Gy with concurrent 5-FU/LV). Chemoradiation was followed by 2 additional cycles of 5-FU/LV. Response to neoadjuvant therapy was based on pathology. RESULTS: From 1999 to 2002, 38 eligible patients were enrolled; 35 completed induction chemotherapy, and 29 went on to surgery. Sixteen patients did not develop metastatic progression, 10 developed metastatic disease, and 12 were unevaluable. There were no pathologic complete responses after induction therapy. Twenty-five of 38 patients suffered grade 3-4 toxicities during induction paclitaxel/cisplatin. Six of the 7 patients who received postoperative therapy suffered grade 3-4 toxicities. Only 3 of 38 (7.9{\%}) eligible patients completed all assigned treatment. The median overall survival was 1.6 years, and the 2-year survival was 40{\%}. CONCLUSIONS: This regimen of neoadjuvant paclitaxel/cisplatin followed by postoperative 5-FU/LV-based chemoradiation did not have a high enough response rate and proved to be too toxic for further development.",
author = "{Bapsi Chakravarthy}, A. and Catalano, {Paul J.} and Mondschein, {Joshua K.} and Rosenthal, {David I.} and Haller, {Daniel G.} and Richard Whittington and Spitz, {Francis R.} and Henry Wagner and Sigurdson, {Elin R.} and Tschetter, {Loren K.} and Bayer, {Gerald K.} and Mulcahy, {Mary Frances} and {Benson III}, {Al B}",
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Bapsi Chakravarthy, A, Catalano, PJ, Mondschein, JK, Rosenthal, DI, Haller, DG, Whittington, R, Spitz, FR, Wagner, H, Sigurdson, ER, Tschetter, LK, Bayer, GK, Mulcahy, MF & Benson III, AB 2013, 'Phase II trial of paclitaxel/cisplatin followed by surgery and adjuvant radiation therapy and 5-fluorouracil/leucovorin for gastric cancer (ECOG E7296)', Gastrointestinal Cancer Research, vol. 5, no. 6, pp. 191-197.

Phase II trial of paclitaxel/cisplatin followed by surgery and adjuvant radiation therapy and 5-fluorouracil/leucovorin for gastric cancer (ECOG E7296). / Bapsi Chakravarthy, A.; Catalano, Paul J.; Mondschein, Joshua K.; Rosenthal, David I.; Haller, Daniel G.; Whittington, Richard; Spitz, Francis R.; Wagner, Henry; Sigurdson, Elin R.; Tschetter, Loren K.; Bayer, Gerald K.; Mulcahy, Mary Frances; Benson III, Al B.

In: Gastrointestinal Cancer Research, Vol. 5, No. 6, 01.11.2013, p. 191-197.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Phase II trial of paclitaxel/cisplatin followed by surgery and adjuvant radiation therapy and 5-fluorouracil/leucovorin for gastric cancer (ECOG E7296)

AU - Bapsi Chakravarthy, A.

AU - Catalano, Paul J.

AU - Mondschein, Joshua K.

AU - Rosenthal, David I.

AU - Haller, Daniel G.

AU - Whittington, Richard

AU - Spitz, Francis R.

AU - Wagner, Henry

AU - Sigurdson, Elin R.

AU - Tschetter, Loren K.

AU - Bayer, Gerald K.

AU - Mulcahy, Mary Frances

AU - Benson III, Al B

PY - 2013/11/1

Y1 - 2013/11/1

N2 - BACKGROUND: Randomized trials have shown an increase in survival with perioperative chemotherapy as well as with postoperative chemoradiation. It was hypothesized that combining induction chemotherapy with postoperative chemoradiation would be well tolerated and improve pathologic complete response. METHODS: Patients with resectable cancers of the stomach/gastroesophageal junction were eligible. Neoadjuvant chemotherapy consisted of 3 cycles of paclitaxel and cisplatin. Adjuvant therapy consisted of 1 cycle of 5-fluorouracil (FU) and leucovorin (LV) followed by chemoradiation (45 Gy with concurrent 5-FU/LV). Chemoradiation was followed by 2 additional cycles of 5-FU/LV. Response to neoadjuvant therapy was based on pathology. RESULTS: From 1999 to 2002, 38 eligible patients were enrolled; 35 completed induction chemotherapy, and 29 went on to surgery. Sixteen patients did not develop metastatic progression, 10 developed metastatic disease, and 12 were unevaluable. There were no pathologic complete responses after induction therapy. Twenty-five of 38 patients suffered grade 3-4 toxicities during induction paclitaxel/cisplatin. Six of the 7 patients who received postoperative therapy suffered grade 3-4 toxicities. Only 3 of 38 (7.9%) eligible patients completed all assigned treatment. The median overall survival was 1.6 years, and the 2-year survival was 40%. CONCLUSIONS: This regimen of neoadjuvant paclitaxel/cisplatin followed by postoperative 5-FU/LV-based chemoradiation did not have a high enough response rate and proved to be too toxic for further development.

AB - BACKGROUND: Randomized trials have shown an increase in survival with perioperative chemotherapy as well as with postoperative chemoradiation. It was hypothesized that combining induction chemotherapy with postoperative chemoradiation would be well tolerated and improve pathologic complete response. METHODS: Patients with resectable cancers of the stomach/gastroesophageal junction were eligible. Neoadjuvant chemotherapy consisted of 3 cycles of paclitaxel and cisplatin. Adjuvant therapy consisted of 1 cycle of 5-fluorouracil (FU) and leucovorin (LV) followed by chemoradiation (45 Gy with concurrent 5-FU/LV). Chemoradiation was followed by 2 additional cycles of 5-FU/LV. Response to neoadjuvant therapy was based on pathology. RESULTS: From 1999 to 2002, 38 eligible patients were enrolled; 35 completed induction chemotherapy, and 29 went on to surgery. Sixteen patients did not develop metastatic progression, 10 developed metastatic disease, and 12 were unevaluable. There were no pathologic complete responses after induction therapy. Twenty-five of 38 patients suffered grade 3-4 toxicities during induction paclitaxel/cisplatin. Six of the 7 patients who received postoperative therapy suffered grade 3-4 toxicities. Only 3 of 38 (7.9%) eligible patients completed all assigned treatment. The median overall survival was 1.6 years, and the 2-year survival was 40%. CONCLUSIONS: This regimen of neoadjuvant paclitaxel/cisplatin followed by postoperative 5-FU/LV-based chemoradiation did not have a high enough response rate and proved to be too toxic for further development.

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Bapsi Chakravarthy A, Catalano PJ, Mondschein JK, Rosenthal DI, Haller DG, Whittington R et al. Phase II trial of paclitaxel/cisplatin followed by surgery and adjuvant radiation therapy and 5-fluorouracil/leucovorin for gastric cancer (ECOG E7296). Gastrointestinal Cancer Research. 2013 Nov 1;5(6):191-197.