Treating Patients on Protocol More Effective, No More Costly

ALEXANDRIA, Va—Treating a patient in a clinical trial—nearly always a cancer patient’s best treatment option—is no more costly and far more effective than giving supposedly less expensive “established” care, reported William P.Peters, MD, PhD, president, director, and chief executive officer of the Barbara Ann Karmanos Cancer Institute, Detroit. Dr. Peters discussed a series of cost and outcome studies that reached this conclusion at the Annual Meeting of the Association of Community Cancer Centers.

In a study of outcomes and costs in non-small-cell lung cancer patients treated on protocol who were matched with similar nonprotocol patients from SEER, Dr. Peters reported that the protocol patients cost less for the first 6 months and had a median survival almost twice as long as the off-protocol patients. The cost of protocol-treated patients became higher at 9 and 11 months because, compared with the off-protocol group, more protocol patients were alive and required treatment.

In a computerized simulation of 1,000 clinical trials, he continued, the average cost of a progression-free month was more than $1,000 less for protocol patients than for nonprotocol patients.

Breast Cancer Transplant Protocols

Similar studies of patients with metastatic breast cancer produced similarly favorable cost and outcome results, with protocol and nonprotocol patients costing nearly the same although the protocol patients required fewer inpatient stays.

Dr. Peters used actual 5-year outcome data from US and South African studies to estimate the cost of conventional treatment and high-dose chemotherapy with bone marrow transplant for metastatic breast cancer. Based on these data, he again performed computerized simulations of 1,000 clinical trials of 100-patient cohorts.

The data showed that, in both countries, high-dose therapy/transplant was more cost-effective than conventional dose therapy in terms of cost per disease-free woman-year. However, conventional dose therapy in the United States was less costly and more effective than similar conventional dose treatment in South Africa. Dr. Peters emphasized that “in each case, treatment with high-dose therapy was more cost-effective than treatment with conventional dose therapy.”

Studies of outcomes and costs of treating advanced breast cancer patients in trials of high-dose chemotherapy followed by bone marrow transplant show that mortality from the procedure has fallen from 28% to 2% between 1980 and 1998 and that inpatient stays have been the biggest cost driver for this mode of treatment, Dr. Peters said.

“Initially done exclusively on an inpatient basis with stays averaging 37 days, transplant at the Karmanos Institute is now almost entirely an outpatient procedure with 5 days the typical stay,” he said

The newer approach to the procedure produces much greater satisfaction; reduced infection rates; greater efficiency, with the transplant unit able to handle three times as many patients; and major reduction in cost, from an average of $150,000 to $65,000. By freeing up resources, the new approach also provides the opportunity to study other diseases in addition to breast cancer.

In answer to a question from the floor, Dr. Peters said that he did not know the total out-of-pocket cost to the patient of co-pays, for a family member to be available to care for the patient, and for other requirements of outpatient transplant. He observed, however, that even when transplant is done on an inpatient basis, someone nearly always stays with the patient whether needed or not.

“The added responsibility of actually caring for the patient in a hotel apartment may add to the caregiver’s quality of life,” Dr. Peters said, “as opposed to sitting around, feeling unneeded and unhelpful, in a hospital unit. Some family members also manage to carry on some business using computers in the apartments.” Session chair David H. Regan, MD, of Northwest Cancer Specialists, Portland, Oregon, added that the ability of women—especially young mothers—to gain more years of life with their families is “priceless.”