What question did this study set out to answer?

To evaluate the safety, maximum-tolerated dose, pharmacokinetics, and biological activity of weekly pegylated interferon alfa-2a in patients with untreated advanced renal cell carcinoma.

March 1, 2001Journal of Clinical Oncology

Phase I Trial of 40-kd Branched Pegylated Interferon Alfa-2a for Patients With Advanced Renal Cell Carcinoma

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To evaluate the safety, maximum-tolerated dose, pharmacokinetics, and biological activity of weekly pegylated interferon alfa-2a in patients with untreated advanced renal cell carcinoma.
Enrolled 27 previously untreated patients into dose-escalation cohorts receiving subcutaneous pegylated interferon alfa-2a weekly.
Escalated doses from 180 µg/wk up to 540 µg/wk in 90-µg increments to determine dose-limiting toxicity and the maximum-tolerated dose.
Assessed serial blood samples for drug pharmacokinetics and immunologic surrogate markers (neopterin and 2'-5' oligoadenylate synthetase).
Identified 540 µg/wk as the maximum-tolerated dose after two patients experienced dose-limiting toxicities (grade 3 ALT elevation and grade 3 fatigue), establishing 450 µg/wk as the recommended dose.
Achieved a 19% partial response rate (5 of 27 patients), with the most frequent toxicities being mild-to-moderate fatigue, fever, headache, myalgia, nausea, and decreased appetite.
Demonstrated sustained drug serum concentrations across dosing intervals with steady-state reached at approximately 5 weeks, alongside parallel prolonged activation of neopterin and 2'-5' oligoadenylate synthetase.

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Implication

Phase I trial demonstrates the tolerability and antitumor activity of pegylated interferon alfa-2a in advanced renal cell carcinoma, suggesting 450 mcg weekly as an effective regimen.

Cite This Study

Motzer et al. (2001) studied this question.

synapsesocial.com/papers/6a755d4a33d16877c7f56e21 https://doi.org/10.1200/jco.2001.19.5.1312

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Implication

Phase I trial demonstrates the tolerability and antitumor activity of pegylated interferon alfa-2a in advanced renal cell carcinoma, suggesting 450 mcg weekly as an effective regimen.

Phase I Trial of 40-kd Branched Pegylated Interferon Alfa-2a for Patients With Advanced Renal Cell Carcinoma

Key Points

Discussion

Implication

Cite This Study

Phase I Trial of 40-kd Branched Pegylated Interferon Alfa-2a for Patients With Advanced Renal Cell Carcinoma

Key Points

Discussion

Implication

Cite This Study

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