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Toxicity analysis of docetaxel, cisplatin, and 5- fluorouracil neoadjuvant chemotherapy in Indian patients with head and neck cancers
Background There is a lack of data that systematically address toxicity with docetaxel, cisplatin, and 5-fluorouracil (TPF) regimen in routine care.
Objective To detect, profile, and quantify the toxicity in Indian patients with head and neck cancers who received neoadjuvant TPF chemotherapy in a routine clinical practice (non-trial setting).
Methods 58 patients with locally advanced head and neck cancer who received TPF chemotherapy were selected for this analysis. They received 2 cycles of TPF chemotherapy every 21 days. The patients were monitored for the occurrence of adverse drug reactions in accordance with Common Terminology Criteria for Adverse Events (version 4.03) during the hospitalization (median length of stay in cycle 1, 10 days), daily (at least until day 8 after chemotherapy initiation), then at days 15 and 20. Descriptive statistics was done and factors predicting for toxicity were identified using logistic regression analysis.
Results The cumulative rate of grade ¦3 anemia, neutropenia, and thrombocytopenia were 12.1%, 56.9%, and 5.2%, respectively. The cumulative incidence of febrile neutropenia was 20.7% (12 of 58 patients). The cumulative incidences of mucositis and diarrhea were 67.2% and 74.1%, respectively. There was no mortality associated with induction chemotherapy, and all of the patients completed the planned 2 cycles of TPF. None of the tested factors predicted for any of the adverse events considered in the study.
Limitations Small, single-center study
Conclusion The incidence of TPF-related toxicity in Indian patients in routine practice is high, and the toxicities differ substantially from the toxicities seen in trial settings.
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Background There is a lack of data that systematically address toxicity with docetaxel, cisplatin, and 5-fluorouracil (TPF) regimen in routine care.
Objective To detect, profile, and quantify the toxicity in Indian patients with head and neck cancers who received neoadjuvant TPF chemotherapy in a routine clinical practice (non-trial setting).
Methods 58 patients with locally advanced head and neck cancer who received TPF chemotherapy were selected for this analysis. They received 2 cycles of TPF chemotherapy every 21 days. The patients were monitored for the occurrence of adverse drug reactions in accordance with Common Terminology Criteria for Adverse Events (version 4.03) during the hospitalization (median length of stay in cycle 1, 10 days), daily (at least until day 8 after chemotherapy initiation), then at days 15 and 20. Descriptive statistics was done and factors predicting for toxicity were identified using logistic regression analysis.
Results The cumulative rate of grade ¦3 anemia, neutropenia, and thrombocytopenia were 12.1%, 56.9%, and 5.2%, respectively. The cumulative incidence of febrile neutropenia was 20.7% (12 of 58 patients). The cumulative incidences of mucositis and diarrhea were 67.2% and 74.1%, respectively. There was no mortality associated with induction chemotherapy, and all of the patients completed the planned 2 cycles of TPF. None of the tested factors predicted for any of the adverse events considered in the study.
Limitations Small, single-center study
Conclusion The incidence of TPF-related toxicity in Indian patients in routine practice is high, and the toxicities differ substantially from the toxicities seen in trial settings.
Click on the PDF icon at the top of this introduction to read the full article.
Background There is a lack of data that systematically address toxicity with docetaxel, cisplatin, and 5-fluorouracil (TPF) regimen in routine care.
Objective To detect, profile, and quantify the toxicity in Indian patients with head and neck cancers who received neoadjuvant TPF chemotherapy in a routine clinical practice (non-trial setting).
Methods 58 patients with locally advanced head and neck cancer who received TPF chemotherapy were selected for this analysis. They received 2 cycles of TPF chemotherapy every 21 days. The patients were monitored for the occurrence of adverse drug reactions in accordance with Common Terminology Criteria for Adverse Events (version 4.03) during the hospitalization (median length of stay in cycle 1, 10 days), daily (at least until day 8 after chemotherapy initiation), then at days 15 and 20. Descriptive statistics was done and factors predicting for toxicity were identified using logistic regression analysis.
Results The cumulative rate of grade ¦3 anemia, neutropenia, and thrombocytopenia were 12.1%, 56.9%, and 5.2%, respectively. The cumulative incidence of febrile neutropenia was 20.7% (12 of 58 patients). The cumulative incidences of mucositis and diarrhea were 67.2% and 74.1%, respectively. There was no mortality associated with induction chemotherapy, and all of the patients completed the planned 2 cycles of TPF. None of the tested factors predicted for any of the adverse events considered in the study.
Limitations Small, single-center study
Conclusion The incidence of TPF-related toxicity in Indian patients in routine practice is high, and the toxicities differ substantially from the toxicities seen in trial settings.
Click on the PDF icon at the top of this introduction to read the full article.