Docetaxel (Taxotere®)-cisplatin (TC): An effective drug combination in gastric carcinoma

A. D. Roth, R. Maibach, G. Martinelli, N. Fazio, M. S. Aapro, O. Pagani, R. Morant, M. M. Borner, R. Herrmann, H. Honegger, F. Cavalli, P. Alberto, M. Castiglione, A. Goldhirsch

Research output: Contribution to journalArticle

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Abstract

Purpose: A multi-centric trial was performed to explore the clinical activity, in terms of response and toxicity (primary objectives), duration of response and survival (secondary objectives), of docetaxel with cisplatin in advanced gastric cancer (AGC). Patients and methods: Patients with measurable unresectable and/or metastatic gastric carcinoma, performance status ≤1, normal hematological, hepatic and renal functions and not pretreated for advanced disease by chemotherapy received up to eight cycles of TC (docetaxel 85 mg/m2 dl, cisplatin 75 mg/m2 dl) q3w. Dose escalation to 100 mg/m2 was performed in five patients and was discontinued for excessive toxicity. Results: Forty-eight patients were accrued. A median of 5 cycles/patient was given. We observed 2 complete and 25 partial responses for an overall intent to treat response rate of 56% (95% CI: 41%-71%). Twelve patients had stable disease for ≥ 9 weeks (3 cycles). The median time to progression and overall survival were 6.6 and 9 months, respectively. Grade ≥ 3 toxicities were neutropenia 81%, anemia 32%, thrombocytopenia 4%, alopecia 36%, fatigue 9%, mucositis 9%, diarrhea 6%, nausea/vomiting 4%, neurologic 2%, and one anaphylaxis precluding treatment administration. We recorded nine episodes of non-fatal febrile neutropenia in eight patients, two of them with docetaxel at 100 mg/m2. There were no direct treatment-related deaths. Conclusions: TC is active in AGC with a high response rate in a multicentric trial. Despite its hematotoxicity, this regimen is well tolerated and can be recycled as originally planned in 78% of the cases. These results may serve as basis for further developments of docetaxel containing regimens in this disease.

Original languageEnglish
Pages (from-to)301-306
Number of pages6
JournalAnnals of Oncology
Volume11
Issue number3
DOIs
Publication statusPublished - 2000

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docetaxel
Drug Combinations
Cisplatin
Stomach
Carcinoma
Stomach Neoplasms
Febrile Neutropenia
Mucositis
Survival
Alopecia
Anaphylaxis
Neutropenia
Nausea
Nervous System
Vomiting
Fatigue
Anemia
Diarrhea

Keywords

  • Chemotherapy
  • Docetaxel
  • Gastric cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Docetaxel (Taxotere®)-cisplatin (TC) : An effective drug combination in gastric carcinoma. / Roth, A. D.; Maibach, R.; Martinelli, G.; Fazio, N.; Aapro, M. S.; Pagani, O.; Morant, R.; Borner, M. M.; Herrmann, R.; Honegger, H.; Cavalli, F.; Alberto, P.; Castiglione, M.; Goldhirsch, A.

In: Annals of Oncology, Vol. 11, No. 3, 2000, p. 301-306.

Research output: Contribution to journalArticle

Roth, AD, Maibach, R, Martinelli, G, Fazio, N, Aapro, MS, Pagani, O, Morant, R, Borner, MM, Herrmann, R, Honegger, H, Cavalli, F, Alberto, P, Castiglione, M & Goldhirsch, A 2000, 'Docetaxel (Taxotere®)-cisplatin (TC): An effective drug combination in gastric carcinoma', Annals of Oncology, vol. 11, no. 3, pp. 301-306. https://doi.org/10.1023/A:1008342013224
Roth, A. D. ; Maibach, R. ; Martinelli, G. ; Fazio, N. ; Aapro, M. S. ; Pagani, O. ; Morant, R. ; Borner, M. M. ; Herrmann, R. ; Honegger, H. ; Cavalli, F. ; Alberto, P. ; Castiglione, M. ; Goldhirsch, A. / Docetaxel (Taxotere®)-cisplatin (TC) : An effective drug combination in gastric carcinoma. In: Annals of Oncology. 2000 ; Vol. 11, No. 3. pp. 301-306.
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abstract = "Purpose: A multi-centric trial was performed to explore the clinical activity, in terms of response and toxicity (primary objectives), duration of response and survival (secondary objectives), of docetaxel with cisplatin in advanced gastric cancer (AGC). Patients and methods: Patients with measurable unresectable and/or metastatic gastric carcinoma, performance status ≤1, normal hematological, hepatic and renal functions and not pretreated for advanced disease by chemotherapy received up to eight cycles of TC (docetaxel 85 mg/m2 dl, cisplatin 75 mg/m2 dl) q3w. Dose escalation to 100 mg/m2 was performed in five patients and was discontinued for excessive toxicity. Results: Forty-eight patients were accrued. A median of 5 cycles/patient was given. We observed 2 complete and 25 partial responses for an overall intent to treat response rate of 56{\%} (95{\%} CI: 41{\%}-71{\%}). Twelve patients had stable disease for ≥ 9 weeks (3 cycles). The median time to progression and overall survival were 6.6 and 9 months, respectively. Grade ≥ 3 toxicities were neutropenia 81{\%}, anemia 32{\%}, thrombocytopenia 4{\%}, alopecia 36{\%}, fatigue 9{\%}, mucositis 9{\%}, diarrhea 6{\%}, nausea/vomiting 4{\%}, neurologic 2{\%}, and one anaphylaxis precluding treatment administration. We recorded nine episodes of non-fatal febrile neutropenia in eight patients, two of them with docetaxel at 100 mg/m2. There were no direct treatment-related deaths. Conclusions: TC is active in AGC with a high response rate in a multicentric trial. Despite its hematotoxicity, this regimen is well tolerated and can be recycled as originally planned in 78{\%} of the cases. These results may serve as basis for further developments of docetaxel containing regimens in this disease.",
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T2 - An effective drug combination in gastric carcinoma

AU - Roth, A. D.

AU - Maibach, R.

AU - Martinelli, G.

AU - Fazio, N.

AU - Aapro, M. S.

AU - Pagani, O.

AU - Morant, R.

AU - Borner, M. M.

AU - Herrmann, R.

AU - Honegger, H.

AU - Cavalli, F.

AU - Alberto, P.

AU - Castiglione, M.

AU - Goldhirsch, A.

PY - 2000

Y1 - 2000

N2 - Purpose: A multi-centric trial was performed to explore the clinical activity, in terms of response and toxicity (primary objectives), duration of response and survival (secondary objectives), of docetaxel with cisplatin in advanced gastric cancer (AGC). Patients and methods: Patients with measurable unresectable and/or metastatic gastric carcinoma, performance status ≤1, normal hematological, hepatic and renal functions and not pretreated for advanced disease by chemotherapy received up to eight cycles of TC (docetaxel 85 mg/m2 dl, cisplatin 75 mg/m2 dl) q3w. Dose escalation to 100 mg/m2 was performed in five patients and was discontinued for excessive toxicity. Results: Forty-eight patients were accrued. A median of 5 cycles/patient was given. We observed 2 complete and 25 partial responses for an overall intent to treat response rate of 56% (95% CI: 41%-71%). Twelve patients had stable disease for ≥ 9 weeks (3 cycles). The median time to progression and overall survival were 6.6 and 9 months, respectively. Grade ≥ 3 toxicities were neutropenia 81%, anemia 32%, thrombocytopenia 4%, alopecia 36%, fatigue 9%, mucositis 9%, diarrhea 6%, nausea/vomiting 4%, neurologic 2%, and one anaphylaxis precluding treatment administration. We recorded nine episodes of non-fatal febrile neutropenia in eight patients, two of them with docetaxel at 100 mg/m2. There were no direct treatment-related deaths. Conclusions: TC is active in AGC with a high response rate in a multicentric trial. Despite its hematotoxicity, this regimen is well tolerated and can be recycled as originally planned in 78% of the cases. These results may serve as basis for further developments of docetaxel containing regimens in this disease.

AB - Purpose: A multi-centric trial was performed to explore the clinical activity, in terms of response and toxicity (primary objectives), duration of response and survival (secondary objectives), of docetaxel with cisplatin in advanced gastric cancer (AGC). Patients and methods: Patients with measurable unresectable and/or metastatic gastric carcinoma, performance status ≤1, normal hematological, hepatic and renal functions and not pretreated for advanced disease by chemotherapy received up to eight cycles of TC (docetaxel 85 mg/m2 dl, cisplatin 75 mg/m2 dl) q3w. Dose escalation to 100 mg/m2 was performed in five patients and was discontinued for excessive toxicity. Results: Forty-eight patients were accrued. A median of 5 cycles/patient was given. We observed 2 complete and 25 partial responses for an overall intent to treat response rate of 56% (95% CI: 41%-71%). Twelve patients had stable disease for ≥ 9 weeks (3 cycles). The median time to progression and overall survival were 6.6 and 9 months, respectively. Grade ≥ 3 toxicities were neutropenia 81%, anemia 32%, thrombocytopenia 4%, alopecia 36%, fatigue 9%, mucositis 9%, diarrhea 6%, nausea/vomiting 4%, neurologic 2%, and one anaphylaxis precluding treatment administration. We recorded nine episodes of non-fatal febrile neutropenia in eight patients, two of them with docetaxel at 100 mg/m2. There were no direct treatment-related deaths. Conclusions: TC is active in AGC with a high response rate in a multicentric trial. Despite its hematotoxicity, this regimen is well tolerated and can be recycled as originally planned in 78% of the cases. These results may serve as basis for further developments of docetaxel containing regimens in this disease.

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