NEW YORK (Reuters Health) – There’s no good evidence that maintenance therapy improves the outcome of small-cell lung cancer (SCLC), according to a meta-analysis published February 25th in Lung Cancer.
“To date, in clinical practice, no maintenance treatment, neither chemotherapy nor interferon-alpha, can be considered due to the lack of large, well-designed, randomized phase III trials addressing their role in this setting,” lead author Dr. Antonio Rossi from S.G. Moscati Hospital, Avellino, Italy, told Reuters Health by email.
He added, “The positive results, in terms of overall survival, reported by chemotherapy and by interferon-alpha should be considered with caution but may supply indications for further trials in this field.”
Dr. Rossi and his colleagues conducted a meta-analysis of 21 randomized controlled trials of consolidation or maintenance therapy in SCLC, including 11 that used chemotherapy, 4 that used interferon-alpha, 2 with interferon-gamma, and 4 that tested other biological agents.
Pooled data from all the studies, involving a total of 3688 patients, showed no difference in overall survival between treatment and control arms.
Survival was significantly better for maintenance chemotherapy and for interferon-alpha, but there was no advantage for interferon-gamma or for other biological agents, and there was significant heterogeneity overall and within the subgroups of treatment.
Data from 2783 patients failed to show an advantage of maintenance or consolidation therapy against progression-free survival, either overall or for any of the individual therapies.
From the limited toxicity data that were available, the authors determined that more patients stopped maintenance therapy due to toxicity from interferon and other biological agents than with the comparative treatment.
“In the last few months we received the first positive results using maintenance therapy for the treatment of advanced non-small cell lung cancer coming from very recent randomized trials in which last generation drugs, such as pemetrexed or erlotinib, were being investigated,” Dr. Rossi said. “So I think that this approach is of interest also in small cell lung cancer, but it should be addressed in the right way, that is, within randomized trials with well defined selection criteria to reduce possible heterogeneity in enrolling patients.”
“I think that new targeted agents may play an important role, with the maintenance approach being the best candidate in this setting possibly due to its safety compared to chemotherapeutics,” Dr. Rossi continued. “However, specific early phase I-II studies should always be performed in order to get better evidence on optimal dosage and activity of these drugs, and only if a positive result is reached specifically in small cell lung cancer, phase III studies might be planned.”
Lung Cancer 2010.
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