Researchers from France have reported that the addition of Thalomid (thalidomide) to chemotherapy improves survival in patients with extensive small cell lung cancer (SCLC). The details of this study were presented at the 2006 annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Ga.

Thalomid is an agent being evaluated for the treatment of several malignancies, especially multiple myeloma. Due to its anti-angiogenesis effect, this agent is being tested in ovarian and lung cancer.

The current trial included 119 patients with extensive SCLC, all of whom initially underwent chemotherapy with a regimen referred to as PCDE (comprising four chemotherapy agents). Patients received prophylactic Neupogen® (filgrastim) with each course of chemotherapy. If patients achieved an anticancer response to PCDE, they were then treated with additional PCDE plus placebo (inactive substitute) or thalomid plus PCDE. Treatment groups were directly compared.

• Overall anticancer responses were achieved in 81.6% of patients treated with the addition of thalomid compared with 62.8% for those treated with PCDE only.
• At one year, 49% of patients treated with thalomid were alive compared with only 30% of patients treated PCDE only.
• Nearly half of the patients treated with thalomid were still alive at one year compared with approximately nine months for those treated with PCDE only.
• One-third of patients discontinued treatment with thalomid due to side effects associated with its treatment.
• Severe constipation and neuropathy (numbness, tingling, and pain in hands or feet) were more common with treatment including thalomid.

The researchers concluded that the addition of thalomid to chemotherapy significantly improves survival for patients with extensive SCLC. However, side effects associated with thalomid led one-third of patients to discontinue treatment.

Comments:  These are interesting results, and it will be important to review the data when it becomes available in published form. Although not specified in the abstract the chemotherapy regimen in this study probably included cisplatin, cyclophosphamide and etoposide and possibly doxorubicin.

Reference: Pujol J, Breton J, Gervais R, et al. A Prospective Randomized Phase III, Double-Blind, Placebo-Controlled Study of Thalidomide in Extended-Disease (ED) SCLC Patients After Response to Chemotherapy (CT): An Intergroup Study FNCLCC Cleo04-IFCT 00-01. Proceedings from the 42nd annual meeting of the American Society of Clinical Oncology (ASCO). Atlanta, Ga. June 2006. Abstract # 7057.

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