Prospectively randomized trial of adjuvant active‐specific immunotherapy for human colorectal cancer

Abstract

Over the last four years a guinea pig model of active‐specific immunotherapy (ASI) with a syngeneic tumor celhbacillus calmette‐Guerin (BCG) vaccine was translated into a prospectively randomized, controlled clinical trial in patients with colorectal cancer. Primary tumors from patients undergoing standard surgical resection were dissociated enzymatically and cryopreserved by techniques that maintain cell viability. Patients with transmural extension of tumor or nodal metastases were randomized into groups treated by resection alone (control) or resection plus ASI. With a mean follow‐up of 28 months (range, 14–24), only 3 of 20 treatment patients had recurrences and none have died, whereas 9 of 20 control patients had recurrences and 4 died. These differences are statistically significant and are sufficiently encouraging to warrant expansion of these studies into other research centers. Cancer 55:1236‐1243, 1985.

Vaccination against tumor cells expressing breast cancer epithelial tumor antigen.

“…Attempts have been made to elicit tumor immunity through inoculation of purified antigens or tumor lysates (1)(2)(3)(4)(5)(6)(7) or anti-idiotypic antibodies directed against tumor-associated antigens (8)(9)(10). Such approaches have met with only limited success, and we have used instead live recombinant vaccinia viruses expressing tumor antigens to immunize against tumor cells.…”

Adjuvant treatment of locally advanced renal cancer with autologous virus-modified tumor vaccines

“…Clinical studies using tumor-cell vaccines in the adjuvant setting have been performed in patients with malignant melanoma and colorectal cancer [5,8]. In renal cancer, experience has been gained only in the treatment of metastatic disease [15,19].…”

“…Also, the comparison of risk-factor-adapted patient subgroups with the historical data gave evidence for an improvement in disease-free survival on vaccination treatment [1,11]. These findings are in accordance with the results of other trials using tumor vaccines in neoplasms distinct from renal-cell carcinoma [5,8].…”

The Treatment of Ovarian Cancer with a Gene Modified Cancer Vaccine: A Phase I Study. Tulane University, New Orleans, Louisiana

“…In colon cancer, Hanna and Hoover (13,14) have conducted a prospective randomized stady comparing surgical tteatment only versus surgery followed by a vaccine of autologous tamor cells witil BCG as the adjuvant. The survival outcome in these patients favored those receiving the vaccine at an early point when only 20 patients had been entered in each arm.…”