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Wednesday 27 September 2006

Topotecan Tops Best Supportive Care for Relapsed Small Cell Lung Cancer

By: Jill Stein

The addition of oral topotecan (Hycamtin®) to best supportive care (BSC) significantly increases overall survival compared with BSC alone in patients with relapsed small cell lung cancer (SCLC), according to phase 3 results presented at the International Association for Lung Cancer (IASLC) International Workshop on Early Invasive Lung Cancer.

"Patients with relapsed SCLC have historically had a bad prognosis," said principal investigator Mary O'Brien, MD, Head of the Lung /Cancer Unit at the Royal Marsden NHS Foundation Trust in London, United Kingdom. In particular, certain groups of patients (e.g. those with poor performance status, extensive disease, and short treatment-free interval) have not been offered any further therapy, she said.

"This is the first phase 3 trial to show that chemotherapy produces a robust survival benefit in patients with relapsed SCLC compared with BSC and thus demonstrates that topotecan added to BSC satisfies a longstanding unmet clinical need of providing an active treatment option to patients who might otherwise only receive BSC."

For the trial, 141 patients who had relapsed SCLC and were ineligible for further standard chemotherapy were randomized to treatment with BSC alone or in combination with oral topotecan 2.3 mg/m2/day for five consecutive days. The regimen was repeated every 21 days.

All participants were stratified for PS 0/1 or 2, gender, liver metastases, and time to progression (TTP).

The primary efficacy endpoint was overall survival.

The 2 treatment groups were similar with respect to baseline demographic and clinical characteristics.

Median overall survival for patients on topotecan plus BSC was 25.9 weeks versus 13.9 weeks for patients assigned to BSC alone (P =.01). The 6-month survival rate was 49% and 26% in the two groups, respectively (P =.01).

Increased survival was observed in patients with TTP with either a short treatment-free interval (TFI) from prior therapy (a TFI of 60 days or less) or a longer TFI (greater than 60 days). For patients with a short TFI, overall survival was 23.3 weeks in the topotecan arm versus 13.2 weeks with BSC alone (P <.05). Overall survival was 28 weeks and 14 weeks, respectively, for patients with a long TFI (P <.05).

Results also showed that overall survival was 20.9 weeks in patients treated with topotecan plus BSC who were PS 2 versus 7.7 weeks for BSC only patients (P <.05). "This is particularly noteworthy given that the treatment of patients with poor performance status has always been a challenge," Dr. O'Brien said.

The topotecan cohort also reported an improvement in symptoms compared with patients treated with BSC alone.

"Overall, our data demonstrate that second-line oral topotecan extends survival in patients with relapsed SCLC by a clinically and statistically significant margin," Dr. O'Brien said. "All patients with relapsed SCLC could potentially benefit from this treatment."

Of the 2.8 million cases of cancer in Europe in 2004, lung cancer remains the most common form, accounting for 13.2% of cases, most of these smoking related.2 Approximately 20% of lung cancer patients have SCLC, and two-thirds already have extensive disease at the time of diagnosis.

Intravenous topotecan is the first agent to be approved in Europe that is specifically indicated for the treatment of relapsed SCLC for whom retreatment with the first-line regimen is not considered appropriate. A licence application for the oral formulation of topotecan is planned.

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