Induction chemotherapy with docetaxel, cisplatin, fluorouracil, and leucovorin for squamous cell carcinoma of the head and neck

A phase I/II trial

A. Dimitrios Colevas, Paul M. Busse, Charles M. Norris, Marvin P. Fried, Roy B. Tishler, Mark Poulin, Richard L. Fabian, T. J. Fitzgerald, A. Dreyfuss, Edward S. Peters, Sudeshna Adak, Rosemary Costello, Jennifer J. Barton, Marshall R. Posner

Research output: Contribution to journalArticle

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Abstract

Purpose: A phase I/II trial of docetaxel, cisplatin, fluorouracil (5- FU), and leucovorin (TPFL5) induction chemotherapy for patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods: Twenty-three previously untreated patients with stage III or IV SCCHN and Eastern Cooperative Oncology Group functional status less than or equal to 2 were treated with TPFL5. Postchemotherapy home support included intravenous fluids, prophylactic antibiotics, and granulocyte colony- stimulating factor (G-CSF). Docetaxel dose was escalated to determine the maximum-tolerated dose (MTD). Fifteen patients were treated with three cycles of TPFL5 at MTD. Patients who achieved either a partial response (PR) or complete response (CR) to three cycles of TPFL5 then received definitive twice-daily radiation therapy. Toxicity and clinical and pathologic response to TPFL5 were assessed. Results: Twenty-three patients received a total of 69 cycles of TPFL5. The MTD was determined to be docetaxel 60 mg/m2. Dose- limiting toxicity (DLT) was neutropenia. Additional significant toxicities at MTD were nausea, mucositis, diarrhea, peripheral neuropathy, and sodium- wasting nephropathy. The overall response rate to TPFL5 was 100%, which included 14 of 23 (61%) clinical CRs and nine of 23 (39%) clinical PRs. Primary-site clinical and pathologic CR rates were 19 of 22 (86%) CRs and 20 of 22 (91%) CRs, respectively. Eight patients had less than a CR in the neck to chemotherapy and, therefore, had postradiation neck dissections, four of which were positive for residual tumor. Conclusion: TPFL5 is a tolerable induction regimen in patients with good performance status. The DLT is neutropenia with significant mucositis, diarrhea, peripheral neuropathy, and sodium-wasting nephropathy. The high response rates to TPFL5 justify further evaluation of this combination of agents in the context of formal clinical trials.

Original languageEnglish (US)
Pages (from-to)1331-1339
Number of pages9
JournalJournal of Clinical Oncology
Volume16
Issue number4
StatePublished - Apr 1998
Externally publishedYes

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docetaxel
Induction Chemotherapy
Leucovorin
Fluorouracil
Cisplatin
Maximum Tolerated Dose
Mucositis
Peripheral Nervous System Diseases
Neutropenia
Diarrhea
Sodium
Neck Dissection
Carcinoma, squamous cell of head and neck
Residual Neoplasm
Granulocyte Colony-Stimulating Factor
Nausea

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Induction chemotherapy with docetaxel, cisplatin, fluorouracil, and leucovorin for squamous cell carcinoma of the head and neck : A phase I/II trial. / Colevas, A. Dimitrios; Busse, Paul M.; Norris, Charles M.; Fried, Marvin P.; Tishler, Roy B.; Poulin, Mark; Fabian, Richard L.; Fitzgerald, T. J.; Dreyfuss, A.; Peters, Edward S.; Adak, Sudeshna; Costello, Rosemary; Barton, Jennifer J.; Posner, Marshall R.

In: Journal of Clinical Oncology, Vol. 16, No. 4, 04.1998, p. 1331-1339.

Research output: Contribution to journalArticle

Colevas, AD, Busse, PM, Norris, CM, Fried, MP, Tishler, RB, Poulin, M, Fabian, RL, Fitzgerald, TJ, Dreyfuss, A, Peters, ES, Adak, S, Costello, R, Barton, JJ & Posner, MR 1998, 'Induction chemotherapy with docetaxel, cisplatin, fluorouracil, and leucovorin for squamous cell carcinoma of the head and neck: A phase I/II trial', Journal of Clinical Oncology, vol. 16, no. 4, pp. 1331-1339.
Colevas, A. Dimitrios ; Busse, Paul M. ; Norris, Charles M. ; Fried, Marvin P. ; Tishler, Roy B. ; Poulin, Mark ; Fabian, Richard L. ; Fitzgerald, T. J. ; Dreyfuss, A. ; Peters, Edward S. ; Adak, Sudeshna ; Costello, Rosemary ; Barton, Jennifer J. ; Posner, Marshall R. / Induction chemotherapy with docetaxel, cisplatin, fluorouracil, and leucovorin for squamous cell carcinoma of the head and neck : A phase I/II trial. In: Journal of Clinical Oncology. 1998 ; Vol. 16, No. 4. pp. 1331-1339.
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abstract = "Purpose: A phase I/II trial of docetaxel, cisplatin, fluorouracil (5- FU), and leucovorin (TPFL5) induction chemotherapy for patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods: Twenty-three previously untreated patients with stage III or IV SCCHN and Eastern Cooperative Oncology Group functional status less than or equal to 2 were treated with TPFL5. Postchemotherapy home support included intravenous fluids, prophylactic antibiotics, and granulocyte colony- stimulating factor (G-CSF). Docetaxel dose was escalated to determine the maximum-tolerated dose (MTD). Fifteen patients were treated with three cycles of TPFL5 at MTD. Patients who achieved either a partial response (PR) or complete response (CR) to three cycles of TPFL5 then received definitive twice-daily radiation therapy. Toxicity and clinical and pathologic response to TPFL5 were assessed. Results: Twenty-three patients received a total of 69 cycles of TPFL5. The MTD was determined to be docetaxel 60 mg/m2. Dose- limiting toxicity (DLT) was neutropenia. Additional significant toxicities at MTD were nausea, mucositis, diarrhea, peripheral neuropathy, and sodium- wasting nephropathy. The overall response rate to TPFL5 was 100{\%}, which included 14 of 23 (61{\%}) clinical CRs and nine of 23 (39{\%}) clinical PRs. Primary-site clinical and pathologic CR rates were 19 of 22 (86{\%}) CRs and 20 of 22 (91{\%}) CRs, respectively. Eight patients had less than a CR in the neck to chemotherapy and, therefore, had postradiation neck dissections, four of which were positive for residual tumor. Conclusion: TPFL5 is a tolerable induction regimen in patients with good performance status. The DLT is neutropenia with significant mucositis, diarrhea, peripheral neuropathy, and sodium-wasting nephropathy. The high response rates to TPFL5 justify further evaluation of this combination of agents in the context of formal clinical trials.",
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T1 - Induction chemotherapy with docetaxel, cisplatin, fluorouracil, and leucovorin for squamous cell carcinoma of the head and neck

T2 - A phase I/II trial

AU - Colevas, A. Dimitrios

AU - Busse, Paul M.

AU - Norris, Charles M.

AU - Fried, Marvin P.

AU - Tishler, Roy B.

AU - Poulin, Mark

AU - Fabian, Richard L.

AU - Fitzgerald, T. J.

AU - Dreyfuss, A.

AU - Peters, Edward S.

AU - Adak, Sudeshna

AU - Costello, Rosemary

AU - Barton, Jennifer J.

AU - Posner, Marshall R.

PY - 1998/4

Y1 - 1998/4

N2 - Purpose: A phase I/II trial of docetaxel, cisplatin, fluorouracil (5- FU), and leucovorin (TPFL5) induction chemotherapy for patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods: Twenty-three previously untreated patients with stage III or IV SCCHN and Eastern Cooperative Oncology Group functional status less than or equal to 2 were treated with TPFL5. Postchemotherapy home support included intravenous fluids, prophylactic antibiotics, and granulocyte colony- stimulating factor (G-CSF). Docetaxel dose was escalated to determine the maximum-tolerated dose (MTD). Fifteen patients were treated with three cycles of TPFL5 at MTD. Patients who achieved either a partial response (PR) or complete response (CR) to three cycles of TPFL5 then received definitive twice-daily radiation therapy. Toxicity and clinical and pathologic response to TPFL5 were assessed. Results: Twenty-three patients received a total of 69 cycles of TPFL5. The MTD was determined to be docetaxel 60 mg/m2. Dose- limiting toxicity (DLT) was neutropenia. Additional significant toxicities at MTD were nausea, mucositis, diarrhea, peripheral neuropathy, and sodium- wasting nephropathy. The overall response rate to TPFL5 was 100%, which included 14 of 23 (61%) clinical CRs and nine of 23 (39%) clinical PRs. Primary-site clinical and pathologic CR rates were 19 of 22 (86%) CRs and 20 of 22 (91%) CRs, respectively. Eight patients had less than a CR in the neck to chemotherapy and, therefore, had postradiation neck dissections, four of which were positive for residual tumor. Conclusion: TPFL5 is a tolerable induction regimen in patients with good performance status. The DLT is neutropenia with significant mucositis, diarrhea, peripheral neuropathy, and sodium-wasting nephropathy. The high response rates to TPFL5 justify further evaluation of this combination of agents in the context of formal clinical trials.

AB - Purpose: A phase I/II trial of docetaxel, cisplatin, fluorouracil (5- FU), and leucovorin (TPFL5) induction chemotherapy for patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods: Twenty-three previously untreated patients with stage III or IV SCCHN and Eastern Cooperative Oncology Group functional status less than or equal to 2 were treated with TPFL5. Postchemotherapy home support included intravenous fluids, prophylactic antibiotics, and granulocyte colony- stimulating factor (G-CSF). Docetaxel dose was escalated to determine the maximum-tolerated dose (MTD). Fifteen patients were treated with three cycles of TPFL5 at MTD. Patients who achieved either a partial response (PR) or complete response (CR) to three cycles of TPFL5 then received definitive twice-daily radiation therapy. Toxicity and clinical and pathologic response to TPFL5 were assessed. Results: Twenty-three patients received a total of 69 cycles of TPFL5. The MTD was determined to be docetaxel 60 mg/m2. Dose- limiting toxicity (DLT) was neutropenia. Additional significant toxicities at MTD were nausea, mucositis, diarrhea, peripheral neuropathy, and sodium- wasting nephropathy. The overall response rate to TPFL5 was 100%, which included 14 of 23 (61%) clinical CRs and nine of 23 (39%) clinical PRs. Primary-site clinical and pathologic CR rates were 19 of 22 (86%) CRs and 20 of 22 (91%) CRs, respectively. Eight patients had less than a CR in the neck to chemotherapy and, therefore, had postradiation neck dissections, four of which were positive for residual tumor. Conclusion: TPFL5 is a tolerable induction regimen in patients with good performance status. The DLT is neutropenia with significant mucositis, diarrhea, peripheral neuropathy, and sodium-wasting nephropathy. The high response rates to TPFL5 justify further evaluation of this combination of agents in the context of formal clinical trials.

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