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Phase 2 Study with Baker's Antifol in Solid Tumors¹

Department of Developmental Therapeutics, The University of Texas System Cancer Center, M. D. Anderson Hospital and Tumor Institute, Houston, Texas 77030 [V. R., S. P. R., R. S. B., M. A. B., W. K. M., M. V., J. U. G., G. P. B., E. J F.], and Vanderbilt University, Nashville, Tennessee 37203 [R. L. B.]

One hundred thirty-eight adults with advanced cancers were treated with Baker's Antifol. The complete response + partial response rate was only 10%. Best responses were obtained in 31 patients with lung adenocarcinoma (complete response + partial response, 13%), in 25 patients with colorectal carcinoma (partial response, 16%), and in 6 patients with renal cell carcinoma (partial response, 50%). Two partial responses occurred in 15 patients with squamous cancer. No significant responses were seen in 27 patients with other adenocarcinomas, 13 with sarcomas, 14 with melanomas, and 8 with miscellaneous tumors. The most frequent toxicities were dermatitis, stomatitis, gastrointestinal symptoms, and mild myelosuppression. The incidence of dermatitis was significantly decreased by shortening the schedule of Baker's Antifol administration from 5 to 3 days. Baker's Antifol has some degree of antitumor activity, and studies of combination of this agent with other effective chemotherapeutic agents are indicated.

¹ Supported in part by Contract NO-1-CM57042 and Grants CA 05831 and 11520 from the National Cancer Institute, NIH, USPHS, Bethesda, Md. 20014.

² To whom requests for reprints should be addressed.

Received 8/ 2/76. Accepted 12/27/76.