BREAST CANCER: Bone-Marrow Studies Find No Clear Benefit
Five studies evaluating the use of high-dose chemotherapy in combination with autologous bone marrow transplants in women with advanced breast cancer were released yesterday, and as expected suggested that the "grueling procedure ... does not prolong ... survival overall." But the studies were far from unequivocal and may "do little to help women decide whether to undertake the treatment. Three studies found no significant difference between the bone-marrow treatment and conventional therapy; one study found a substantial survival rate advantage in the bone marrow treatment; and one found no significant difference in survival rates but a slower relapse rate for the bone marrow transplant patients. The findings were released by the American Society of Clinical Oncologists, which said "it was too soon to pass final judgement." The society emphasized that "the findings should be considered preliminary," and that "numbers might change as the data were analyzed more fully (Grady, New York Times, 4/16). A breakdown of the five studies:
- The lone study to show a clear benefit was conducted at the University of Witwatersrand Medical School in South Africa; it studied 154 women with "high-risk" cancer, defined as cancer that has spread to at least 10 underarm lymph nodes. One-fourth of women receiving the high-dose chemotherapy had relapsed after five years, compared to 66% of the control group, which received a lower dose; mortality was 17% "in the high-dose arm, compared with 35% in the standard dose arm.
- A Scandinavian study of 525 women with cancer that spread to the lymph nodes found no benefit in the high-dose regimen: 40 women in the experimental group died and 78 relapsed, compared to 40 deaths and 50 relapses in the controlled group.
- Researchers in the Eastern Cooperative Oncology Group, which studied 553 women with metastatic cancer that had spread to the bones or organs found no benefit in the high-dose regimen: 32% of women in the experimental group survived over three years, compared to 38% of women in the control group.
- A study by French researchers at the Tenon Hospital in Paris of 61 women with metastatic cancer found a slight but statistically insignificant advantage for high-dose patients, with an 18.5% survival rate over five years for women in the control group and a 29.8% rate in the experimental group. However, although the relapse rate for both groups was almost exactly the same after five years (about 91%), the experimental group showed a much lower three-year relapse rate (50.8% - 79.3%), suggesting "high-dose chemotherapy could potentially offer a better quality of life with a longer 'off-therapy' period.
- The largest study, of 783 women with cancer that had spread to the lymph nodes, by researchers at the Barbara Karmanos Cancer Institute in Detroit, found no statistically significant advantage in survival- or relapse-rate in the bone-marrow therapy, with 68% of experimental patients surviving three years versus 64% of the control group (ASOC summary of findings, 4/15). However, lead researcher Dr. William Peters said his study "may yet show a survival advantage for the transplant group; it's too soon to say" (McCullough, Philadelphia Inquirer, 4/16).
- Aetna U.S. Healthcare head of medical clinic research review Dr. Joseph Carver: "The results are still equivocal. All it says is that we need to do more (clinical) trials, and get on the bandwagon that is the best strategy for getting answers" (Brown, Washington Post, 4/16).
- Komen Breast Cancer Foundation CEO Susan Braun: "It would be irresponsible for any insurance carrier to change its policies based on these studies. In fact, these studies should encourage insurance carriers to support ongoing clinical trials in order to obtain more definitive data" (release, 4/15).
- American Association of Health Plans President Karen Ignagni: "There is an important lesson to be learned: political, judicial, or media activism is not a substitute for scientific evidence. By rushing to mandate coverage of this treatment before its efficacy has been clearly proven, lawmakers may have unintentionally delayed research findings and subjected women to unknown risk" (release, 4/15).
- ASCO President Dr. Allen Lichter: "The fact that you see a positive study is encouraging. The fact that you see negative ones in the same population says to me that the true difference is not going to be enormous, or everybody would see it. This is not like penicillin and pneumonia, where you can't miss it."
- Mayo Clinic's Dr. Lynn Hartmann: "There's a population of women who have been told that their only hope of a cure is a transplant, and I think we need to stop saying that" (New York Times, 4/16)
- National Breast Cancer Coalition President Fran Visco: "The trials show no benefit ... our recommendation would be not to try" bone-marrow transplants (Chicago Tribune, 4/16).