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Oral Vinorelbine Offers Flexibility and Convenience in Treating Non-Small-Cell Lung Cancer: Presented at ICACT

By Shazia Qureshi

PARIS, FRANCE -- February 6, 2008 -- Combination treatment with oral vinorelbine and radiation after induction chemotherapy with oral vinorelbine and cisplatin is a feasible and more flexible alternative to intravenous (IV) vinorelbine in stage III non-small-cell lung cancer (NSCLC), according to research reported here at the 19th International Congress on Anti-Cancer Treatment (ICACT).

In addition, patients' compliance with the oral regimen was high, said lead investigator Vittorio Gebbia, MD, PhD, Researcher in Medical Oncology, Department of Experimental Oncology, University of Palermo, Palermo, Italy.

Vinorelbine is a mitotic inhibitor used in the treatment of breast cancer and NSCLC. It is mainly used in its intravenous formulation. Recently, an oral formulation has become available in Europe, which is an advantage for patients because it is well known that patients prefer oral chemotherapy over IV chemotherapy, Dr. Gebbia noted in a presentation on February 5.

The 21 patients in the study had inoperable stage IIIA or IIIB NSCLC that was diagnosed histologically. None of the patients had previously received treatment for their cancer. The median age of the patients was 58 years.

Among the 21 patients, 12 had adenocarcinoma, 8 had squamous cell carcinoma, and 1 patient had large-cell carcinoma. The median Eastern Cooperative Oncology Group Performance Status (ECOG PS) in the overall group was 1. An ECOG PS of 1 meant that patients were restricted in performing strenuous activities but were ambulatory and able to carry out light activities such as light house work or office work.

In the study, patients received two phases of treatment. The first phase was 80 mg/m² of cisplatin plus 25 mg/m² of intravenous vinorelbine on the first day, then 60 mg/m² of oral vinorelbine on the day 8 every 3 weeks over 3 cycles of treatment. If there were no severe adverse effects, the dose of oral vinorelbine could be raised to 80 mg/m².

In the second phase of treatment, Dr. Gebbia and his team gave patients 60 mg/m² of oral vinorelbine on day 1 and also on the days 8, 15, 28, 35, and 41 over a treatment cycle. During the same period patients received radiation therapy at a daily dose of 1.8 to 2.0 Gy fractions, and the total dose was 65 Gy.

Dr. Gebbia reported that after all treatment was ended, the median overall survival was 18.4 months and median progression-free survival was 11.8 months.

After the first phase of treatment the rate of objective response was 50%; no patients achieved a complete response. After the second phase of treatment, 20% of patients achieved a complete response and the objective response rate was 64%.

According to Dr. Gebbia, the dose of oral vinorelbine in the second phase of treatment was reduced in most patients because of adverse effects. This meant decreasing the dose from 60 mg/m² to 40 or 50 mg/m² in 85% of patients. In addition, in 5 patients, radiation therapy was stopped because of adverse effects before the final target dose of 65 Gy was reached.

The study showed that the most common severe adverse effects associated with radiation plus oral vinorelbine were esophagitis in 20% of patients, febrile neutropenia in 10% of patients, and thrombocytopenia in 10%.

Dr. Gebbia acknowledged that the study results should not be taken as conclusive because the number of patients was small and there was no comparison group. However, he indicated that the results were interesting because "the oral formulation of vinorelbine allows significant flexibility of treatment and better convenience for patients."


[Presentation title: Concomitant Oral Vinorelbine and Radiotherapy After Induction Chemotherapy With Oral Vinorelbine and Cisplatin in Stage III Non-Small Cell Lung Cancer. Abstract OR 36]

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