What question did this study set out to answer?

To review and characterize the single-agent safety and tolerability profile of gemcitabine in patients with solid tumors.

Gemcitabine—a safety review

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Pooled analysis reveals mild toxicity and high tolerability of gemcitabine across solid tumor trials, indicating a favorable clinical safety profile.

To review and characterize the single-agent safety and tolerability profile of gemcitabine in patients with solid tumors.
Pooled safety review of 979 patients across 22 completed clinical studies.
Evaluated a 28-day cycle regimen (days 1, 8, and 15) at doses of 800–1250 mg/m² covering nearly 11,000 protocol-defined injections.
WHO grade 3 and 4 hematological toxicities occurred for hemoglobin (6.8% and 1.3%), leukocytes (8.6% and 0.7%), neutrophils (19.3% and 6.0%), and platelets (4.1% and 1.1%), with myelosuppression being short-lived.
Non-laboratory grade 3 or 4 toxicities exceeding 1% incidence were nausea and vomiting (18.4%), pulmonary toxicity (1.4%), and infection (1.2%).
Of nearly 11,000 planned injections, 94% were administered and only 14% required dose reductions.

Aapro et al. (1998) studied this question.

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View Full Paper

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Authors

Pooled analysis reveals mild toxicity and high tolerability of gemcitabine across solid tumor trials, indicating a favorable clinical safety profile.

To review and characterize the single-agent safety and tolerability profile of gemcitabine in patients with solid tumors.
Pooled safety review of 979 patients across 22 completed clinical studies.
Evaluated a 28-day cycle regimen (days 1, 8, and 15) at doses of 800–1250 mg/m² covering nearly 11,000 protocol-defined injections.
WHO grade 3 and 4 hematological toxicities occurred for hemoglobin (6.8% and 1.3%), leukocytes (8.6% and 0.7%), neutrophils (19.3% and 6.0%), and platelets (4.1% and 1.1%), with myelosuppression being short-lived.
Non-laboratory grade 3 or 4 toxicities exceeding 1% incidence were nausea and vomiting (18.4%), pulmonary toxicity (1.4%), and infection (1.2%).
Of nearly 11,000 planned injections, 94% were administered and only 14% required dose reductions.

Aapro et al. (1998) studied this question.

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