Overall, we found neither evidence that the addition of pTE to antineoplastic treatment reduced the risk of death or disease progression nor that it improved the rate of tumour responses to antineoplastic treatment. For thymosin α1, there was a trend for a reduced risk of dying and of improved DFS. There was preliminary evidence that pTE lowered the risk of severe infectious complications in patients undergoing chemotherapy or radiotherapy.
Prospective evaluation of thymosin fraction V immunotherapy in patients with non-small cell lung cancer receiving vindesine, doxorubicin, and cisplatin (VAP) chemotherapy.
One hundred five patients with advanced non-small cell lung cancer were randomized to receive thymosin fraction V immunotherapy during remission induction chemotherapy with vindesine, doxorubicin, and cisplatin (VAP). Fifty-four patients received VAP alone. Fifty-one patients received VAP + thymosin. Both groups were comparable; most patients were male, with a good performance status and with the diagnosis of adenocarcinoma. Among 99 evaluable patients, response was seen in 24 (2 CRs, 22 PRs) of 53 (45%) patients treated with VAP and 10 (all PRs) of 46 (22%) patients treated with VAP + thymosin (p = 0.03). VAP-treated patients responded better than those treated with VAP + thymosin in each tumor category: adenocarcinoma, 50% of 36 patients versus 22% of 27 patients; squamous cell carcinoma, 29% of 14 patients versus 21% of 13 patients; undifferentiated carcinoma, 67% of three patients versus 17% of six patients. Median survival duration was 34 weeks versus 25 weeks in favor of the VAP-treated group (p = 0.14). Thymosin treatment resulted in decreased graft-vs.-host reaction (p = 0.01) and increased suppressor effect on normal mitogen response to Con-A (p = 0.17). The activity of VAP chemotherapy is comparable with the most effective multidrug regimens of the present time in patients with advanced non-small cell tumors. The addition of thymosin immunotherapy appeared to have a negative effect on the activity of VAP.