Prospective randomized evaluation of the role of limb-sparing surgery, radiation therapy, and adjuvant chemoimmunotherapy in the treatment of adult soft-tissue sarcomas
Rosenberg, S.A.; Kent, H.; Costa, J.; Webber, B.L.; Young, R.; Chabner, B.; Baker, A.R.; Brennan, M.F.; Chretien, P.B.; Cohen, M.H.; deMoss, E.V.; Sears, H.F.; Seipp, C.; Simon, R.
Surgery 84(1): 62-69
1978
ISSN/ISBN: 0039-6060 PMID: 663826 Document Number: 137845
Between May 1975 and June 1977, 49 patients were entered into a prospective randomized evaluation of the role of limb-sparing surgery and adjuvant chemoimmunotherapy in the treatment of adult patients with clinically localized soft-tissue sarcomas. Patients with extremity soft-tissue sarcomas were randomized to receive amputation at or above the joint proximal to the tumor or to receive a limb-sparing operation that preserved function of the extremity followed by postoperative radiotherapy. All patients with extremity and truncal sarcomas were randomized to receive either adjuvant chemotherapy with escalating doses of adriamycin and cyclophosphamide plus 6 cycles of high-dose methotrexate or the same chemotherapy plus immunotherapy with i.v. and s.c. Corynebacterium parvum [Propionibacterium acnes]. Treatment groups were compared directly as well as analyzed with respect to 66 comparable historical control patients treated with radical surgery but no adjuvant chemotherapy or radiation therapy. Actuarial analysis of current protocol patients as compared with historical controls revealed an improvement in disease-free interval (P < 0.001) as well as improved survival (P < 0.001). Five recurrences were seen in the 49 protocol patients. Only 1 local recurrence occurred in 16 patients with extremity lesions randomized to receive limb-sparing surgery plus radiation therapy. Adjuvant chemotherapy with adriamycin, cyclophosphamide and methotrexate may be of benefit in preventing disease recurrence in adult patients with soft-tissue sarcomas. Limb-sparing surgery plus radiation therapy may be as effective as radical amputation in achieving local control in this disease.