Phase II trial of docetaxel, cisplatin, fluorouracil, and leucovorin as induction for squamous cell carcinoma of the head and neck

A. D. Colevas, C. M. Norris, R. B. Tishler, Marvin P. Fried, H. I. Gomolin, P. Amrein, A. Nixon, C. Lamb, R. Costello, J. Barton, R. Read, S. Adak, M. R. Posner

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Abstract

Purpose: To evaluate the toxicity and efficacy of a 4-day regimen of docetaxel, cisplatin, fluorouracil, and leucovorin (TPFL4) in patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods: Thirty previously untreated patients with stage III or IV SCCHN and Eastern Cooperative Oncology Group functional status of 2 or less were treated with TPFL4. Postchemotherapy support included prophylactic growth factors and antibiotics. Patients who achieved a complete response (CR) or partial response (PR) to three cycles of TPFL4 received definitive twice-daily radiation therapy. The primary end points were toxicity and response to TPFL4. Results: Eighty-five cycles were administered to 30 patients. The major acute toxicities to TPFL4 were mucositis and nausea. One patient died of neutropenic sepsis during therapy. Additional major toxicities were neutropenia, anorexia, nephropathy, neuropathy, and diarrhea. Fourteen percent of all cycles were associated with hospitalization for toxicity. The overall clinical response rate to TPFL4 was 93%, with 63% CRs and 30% PRs. Primary tumor site clinical and pathologic response rates were 93% and 68%, respectively. Conclusion: TPFL4 has an acceptable toxicity profile in good-performance-status patients. Modification of the 5-day TPFL regimen (TPFL5: shorter chemotherapy infusion time, earlier intervention with growth factors and antibiotics) led to fewer episodes of febrile neutropenia and hospitalization. Response rates to TPFL justify further evaluation of combinations of these agents in the context of formal clinical trials.

Original languageEnglish (US)
Pages (from-to)3503-3511
Number of pages9
JournalJournal of Clinical Oncology
Volume17
Issue number11
StatePublished - Nov 1999
Externally publishedYes

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docetaxel
Leucovorin
Fluorouracil
Cisplatin
Intercellular Signaling Peptides and Proteins
Hospitalization
Anti-Bacterial Agents
Febrile Neutropenia
Mucositis
Anorexia
Carcinoma, squamous cell of head and neck
Neutropenia
Nausea
Diarrhea
Sepsis
Radiotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Colevas, A. D., Norris, C. M., Tishler, R. B., Fried, M. P., Gomolin, H. I., Amrein, P., ... Posner, M. R. (1999). Phase II trial of docetaxel, cisplatin, fluorouracil, and leucovorin as induction for squamous cell carcinoma of the head and neck. Journal of Clinical Oncology, 17(11), 3503-3511.

Phase II trial of docetaxel, cisplatin, fluorouracil, and leucovorin as induction for squamous cell carcinoma of the head and neck. / Colevas, A. D.; Norris, C. M.; Tishler, R. B.; Fried, Marvin P.; Gomolin, H. I.; Amrein, P.; Nixon, A.; Lamb, C.; Costello, R.; Barton, J.; Read, R.; Adak, S.; Posner, M. R.

In: Journal of Clinical Oncology, Vol. 17, No. 11, 11.1999, p. 3503-3511.

Research output: Contribution to journalArticle

Colevas, AD, Norris, CM, Tishler, RB, Fried, MP, Gomolin, HI, Amrein, P, Nixon, A, Lamb, C, Costello, R, Barton, J, Read, R, Adak, S & Posner, MR 1999, 'Phase II trial of docetaxel, cisplatin, fluorouracil, and leucovorin as induction for squamous cell carcinoma of the head and neck', Journal of Clinical Oncology, vol. 17, no. 11, pp. 3503-3511.
Colevas, A. D. ; Norris, C. M. ; Tishler, R. B. ; Fried, Marvin P. ; Gomolin, H. I. ; Amrein, P. ; Nixon, A. ; Lamb, C. ; Costello, R. ; Barton, J. ; Read, R. ; Adak, S. ; Posner, M. R. / Phase II trial of docetaxel, cisplatin, fluorouracil, and leucovorin as induction for squamous cell carcinoma of the head and neck. In: Journal of Clinical Oncology. 1999 ; Vol. 17, No. 11. pp. 3503-3511.
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abstract = "Purpose: To evaluate the toxicity and efficacy of a 4-day regimen of docetaxel, cisplatin, fluorouracil, and leucovorin (TPFL4) in patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods: Thirty previously untreated patients with stage III or IV SCCHN and Eastern Cooperative Oncology Group functional status of 2 or less were treated with TPFL4. Postchemotherapy support included prophylactic growth factors and antibiotics. Patients who achieved a complete response (CR) or partial response (PR) to three cycles of TPFL4 received definitive twice-daily radiation therapy. The primary end points were toxicity and response to TPFL4. Results: Eighty-five cycles were administered to 30 patients. The major acute toxicities to TPFL4 were mucositis and nausea. One patient died of neutropenic sepsis during therapy. Additional major toxicities were neutropenia, anorexia, nephropathy, neuropathy, and diarrhea. Fourteen percent of all cycles were associated with hospitalization for toxicity. The overall clinical response rate to TPFL4 was 93{\%}, with 63{\%} CRs and 30{\%} PRs. Primary tumor site clinical and pathologic response rates were 93{\%} and 68{\%}, respectively. Conclusion: TPFL4 has an acceptable toxicity profile in good-performance-status patients. Modification of the 5-day TPFL regimen (TPFL5: shorter chemotherapy infusion time, earlier intervention with growth factors and antibiotics) led to fewer episodes of febrile neutropenia and hospitalization. Response rates to TPFL justify further evaluation of combinations of these agents in the context of formal clinical trials.",
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T1 - Phase II trial of docetaxel, cisplatin, fluorouracil, and leucovorin as induction for squamous cell carcinoma of the head and neck

AU - Colevas, A. D.

AU - Norris, C. M.

AU - Tishler, R. B.

AU - Fried, Marvin P.

AU - Gomolin, H. I.

AU - Amrein, P.

AU - Nixon, A.

AU - Lamb, C.

AU - Costello, R.

AU - Barton, J.

AU - Read, R.

AU - Adak, S.

AU - Posner, M. R.

PY - 1999/11

Y1 - 1999/11

N2 - Purpose: To evaluate the toxicity and efficacy of a 4-day regimen of docetaxel, cisplatin, fluorouracil, and leucovorin (TPFL4) in patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods: Thirty previously untreated patients with stage III or IV SCCHN and Eastern Cooperative Oncology Group functional status of 2 or less were treated with TPFL4. Postchemotherapy support included prophylactic growth factors and antibiotics. Patients who achieved a complete response (CR) or partial response (PR) to three cycles of TPFL4 received definitive twice-daily radiation therapy. The primary end points were toxicity and response to TPFL4. Results: Eighty-five cycles were administered to 30 patients. The major acute toxicities to TPFL4 were mucositis and nausea. One patient died of neutropenic sepsis during therapy. Additional major toxicities were neutropenia, anorexia, nephropathy, neuropathy, and diarrhea. Fourteen percent of all cycles were associated with hospitalization for toxicity. The overall clinical response rate to TPFL4 was 93%, with 63% CRs and 30% PRs. Primary tumor site clinical and pathologic response rates were 93% and 68%, respectively. Conclusion: TPFL4 has an acceptable toxicity profile in good-performance-status patients. Modification of the 5-day TPFL regimen (TPFL5: shorter chemotherapy infusion time, earlier intervention with growth factors and antibiotics) led to fewer episodes of febrile neutropenia and hospitalization. Response rates to TPFL justify further evaluation of combinations of these agents in the context of formal clinical trials.

AB - Purpose: To evaluate the toxicity and efficacy of a 4-day regimen of docetaxel, cisplatin, fluorouracil, and leucovorin (TPFL4) in patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods: Thirty previously untreated patients with stage III or IV SCCHN and Eastern Cooperative Oncology Group functional status of 2 or less were treated with TPFL4. Postchemotherapy support included prophylactic growth factors and antibiotics. Patients who achieved a complete response (CR) or partial response (PR) to three cycles of TPFL4 received definitive twice-daily radiation therapy. The primary end points were toxicity and response to TPFL4. Results: Eighty-five cycles were administered to 30 patients. The major acute toxicities to TPFL4 were mucositis and nausea. One patient died of neutropenic sepsis during therapy. Additional major toxicities were neutropenia, anorexia, nephropathy, neuropathy, and diarrhea. Fourteen percent of all cycles were associated with hospitalization for toxicity. The overall clinical response rate to TPFL4 was 93%, with 63% CRs and 30% PRs. Primary tumor site clinical and pathologic response rates were 93% and 68%, respectively. Conclusion: TPFL4 has an acceptable toxicity profile in good-performance-status patients. Modification of the 5-day TPFL regimen (TPFL5: shorter chemotherapy infusion time, earlier intervention with growth factors and antibiotics) led to fewer episodes of febrile neutropenia and hospitalization. Response rates to TPFL justify further evaluation of combinations of these agents in the context of formal clinical trials.

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