DENVER (FRONTLINE MEDICAL NEWS) – An adjuvant regimen of carboplatin plus vinorelbine is well tolerated and efficacious in patients who have undergone complete resection of early non–small cell lung cancer (NSCLC), results from a multicenter phase II trial suggested.

The 74 patients in SWITCH 1 received carboplatin plus intravenous vinorelbine on day 1, with a switch to oral vinorelbine on day 8. A total of four cycles of a 21-day regimen were planned.

Main results reported at a world lung cancer conference sponsored by the International Association for the Study of Lung Cancer showed that the regimen was well tolerated, with higher-grade neutropenia seen in only about a quarter of patients and no deaths because of toxicity. More than four-fifths of patients completed all of the planned treatment, and median survival was nearly 6 years.

“Adjuvant chemotherapy with carboplatin and vinorelbine given [intravenously] and switched to oral formula is feasible, tolerable, and effective in early-stage NSCLC,” commented first author Dr. Vitezslav Kolek, a pulmonary oncologist at University Hospital in Olomouc, Czech Republic.

Although comparison with large phase III adjuvant trials is problematic, he acknowledged, “this regimen gives better comfort to the patients, and provides high dose intensity and more completed treatments, compared with cisplatin-based trials. And the present regimen achieved comparable survival to cisplatin-based therapy.”

“The take-home message could be that we don’t have reliable, routinely used predictors in the adjuvant setting. Under these conditions, probably the most intensive [therapy] doesn’t mean the best,” he concluded.

Invited discussant Dr. Giorgio V. Scagliotti of the department of oncology at the University of Torino (Italy), expressed some reservations about the trial. He took issue with the lack of presentation of a statistical hypothesis and with the cross-trial comparison, and he noted that the study population differed somewhat from that typically seen in the clinic.

“The most proven regimen is cisplatin-vinorelbine. … Cisplatin doublets with proven efficacy in advanced disease remain the standard of care for adjuvant chemotherapy,” he contended. “For elderly or unfit patients, carboplatin may be considered in individual cases.”

Introducing the trial, Dr. Kolek noted that carboplatin and cisplatin have not been directly compared in the adjuvant setting. The combination of cisplatin and vinorelbine, however, is known to result in some deaths due to toxicity, and a large share of patients are unable to complete the therapy. In addition, oral vinorelbine seems to perform as well as the intravenous formulation, and patients generally prefer oral therapy, he said.

The patients enrolled in SWITCH 1 had undergone complete resection of stage IB, II, or IIIA NSCLC. The median age was 64 years, and 72% were male. Sixty-two percent had squamous histology.

The mean relative dose intensity was 83% for oral vinorelbine, 93% for intravenous vinorelbine, and 89% for carboplatin, Dr. Kolek reported. The mean number of cycles of chemotherapy received was 3.8 per patient and, overall, 82% of patients completed the planned therapy.

With a median follow-up of 4.7 years, median disease-free and overall survival were 4.4 years and 5.9 years, respectively. Corresponding 5-year rates were 48% and 56%.

The most common grade 3 or 4 toxicities per cycle were neutropenia (seen in 26% of patients), leukopenia (16%), alopecia (12%), and anemia (8%). None of the patients died from treatment toxicity.

Dr. Kolek reported that he receives honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, Pierre Fabre, and Roche.


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