CODE (cisplatin, vincristine, doxorubicin, etoposide) plus granulocyte colony-stimulating factor in advanced non-small-cell lung cancer: A Hoosier oncology group phase II trial

A. Sandler, C. Blanke, F. Monaco, M. A. Carey, R. Ansari, B. Fisher, C. H. Spiridonidis, Lawrence Einhorn, C. Nichols

Research output: Contribution to journalArticle

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Abstract

This phase II trial investigated the activity and toxicity of CODE (cisplatin, vincristine, doxorubicin, etoposide) chemotherapy with the addition of granulocyte colony-stimulating factor (G-CSF) in patients who had chemotherapy-naive, advanced, or metastatic non-small-cell lung cancer. Treatment consisted of cisplatin, 25 mg/m2, administered weeks 1 through 9; vincristine, 1 mg/m2, weeks 1, 2, 4, 6, and 8; doxorubicin, 40 mg/m2, weeks 1, 3, 5, 7, and 9; and etoposide, 80 mg/m2 intravenously day 1 and 160 mg/m2 orally, days 2 and 3 on weeks 1, 3, 5, 7, and 9. Granulocyte colony- stimulating factor, 5 μg/kg, was administered subcutaneously on all days that patients were not receiving chemotherapy. From April 1992 through April 1993, 42 patients were entered on study. The principal toxicities were hematologic. Grade 3-4 anemia was seen in 21 patients. Grade 3-4 thrombocytopenia was seen in 9 patients. Grade 3-4 neutropenia occurred in 29 patients. Eight patients experienced a neutropenic febrile episode requiring antibiotics. Nonhematologic toxicities included weight loss and fatigue. Responses were seen in 10 of 42 patients, for an overall response rate of 24% (95% confidence interval, 12%-39%) and a median survival of 7.1 months. The CODE chemotherapy regimen has activity similar to other previously described cisplatin-based regimens, with a significant amount of both hematologic and nonhematologic toxicity. Its continued use in patients who have previously untreated nonsmall-cell lung cancer cannot be recommended, based on the results of this study.

Original languageEnglish (US)
Pages (from-to)294-297
Number of pages4
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume21
Issue number3
DOIs
StatePublished - Jun 1998

Fingerprint

Vincristine
Granulocyte Colony-Stimulating Factor
Etoposide
Non-Small Cell Lung Carcinoma
Doxorubicin
Cisplatin
Drug Therapy
Neutropenia
Fatigue
Anemia
Weight Loss
Fever
Confidence Intervals
Anti-Bacterial Agents
Survival

Keywords

  • Chemotherapy
  • Non-small-cell lung cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

CODE (cisplatin, vincristine, doxorubicin, etoposide) plus granulocyte colony-stimulating factor in advanced non-small-cell lung cancer : A Hoosier oncology group phase II trial. / Sandler, A.; Blanke, C.; Monaco, F.; Carey, M. A.; Ansari, R.; Fisher, B.; Spiridonidis, C. H.; Einhorn, Lawrence; Nichols, C.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 21, No. 3, 06.1998, p. 294-297.

Research output: Contribution to journalArticle

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abstract = "This phase II trial investigated the activity and toxicity of CODE (cisplatin, vincristine, doxorubicin, etoposide) chemotherapy with the addition of granulocyte colony-stimulating factor (G-CSF) in patients who had chemotherapy-naive, advanced, or metastatic non-small-cell lung cancer. Treatment consisted of cisplatin, 25 mg/m2, administered weeks 1 through 9; vincristine, 1 mg/m2, weeks 1, 2, 4, 6, and 8; doxorubicin, 40 mg/m2, weeks 1, 3, 5, 7, and 9; and etoposide, 80 mg/m2 intravenously day 1 and 160 mg/m2 orally, days 2 and 3 on weeks 1, 3, 5, 7, and 9. Granulocyte colony- stimulating factor, 5 μg/kg, was administered subcutaneously on all days that patients were not receiving chemotherapy. From April 1992 through April 1993, 42 patients were entered on study. The principal toxicities were hematologic. Grade 3-4 anemia was seen in 21 patients. Grade 3-4 thrombocytopenia was seen in 9 patients. Grade 3-4 neutropenia occurred in 29 patients. Eight patients experienced a neutropenic febrile episode requiring antibiotics. Nonhematologic toxicities included weight loss and fatigue. Responses were seen in 10 of 42 patients, for an overall response rate of 24{\%} (95{\%} confidence interval, 12{\%}-39{\%}) and a median survival of 7.1 months. The CODE chemotherapy regimen has activity similar to other previously described cisplatin-based regimens, with a significant amount of both hematologic and nonhematologic toxicity. Its continued use in patients who have previously untreated nonsmall-cell lung cancer cannot be recommended, based on the results of this study.",
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