D-R-A-F-T

Report on High-Dose Chemotherapy Phase III Trials Studies
Presented at ASCO Spring Conference, 1999

In this study, the regression-free survival and overall survival for the high-risk breast cancer patients in this HDC/SCR study are as follows (median followup was 74 months, range was 47-123 months):
 

As one of the people in the Stage IIIB stratum of this study, my particular interest in this one study is that the statistics for people with IBC (Stage IIIB) at the time I was diagnosed were 14 months median survival and 20 percent 5 year survival. To me, being able to look at a 55 percent survival rate on a median followup from diagnosis of 74 months looks quite good. Taken the opposite way, the mortality rates are 45 percent at 6+ years versus 80 percent at 5 years for people who received the treatment that was standard at the time I was diagnosed. I'll take those numbers in a heartbeat!

As for the four studies reported in the NCI announcement on 15 April, the short version is that three of the studies for non-metastatic disease are right on track. The American Society for Blood and Marrow Transplantation had an evening symposium with several of the studies' principal authors where the current numbers were discussed in MUCH more detail.

The studies having preliminary data reported in April and more detailed information presented at ASCO were:

• Stadtmauer - Philadelphia Intergroup study
• Peters - CALGB/SWOG/NCIC study
• Bergh - Swedish study
• Bezwoda - South African study; this study has since been discovered to have reported falsified data.  It is our view that, since the principal investigator cheated, this study should simply be thrown out, i.e., no decisions about receiving or not receiving HDC/SCR should be based on ANYTHING reported in this study.

In the Philadelphia study. the investigators used STAMP V (cytoxan, thiotepa, carboplatin for four days each) for their chemo. Their non-study arm was CMF. They clearly stated that they could NOT interpolate their results for patients with metastatic disease to HRBC patients who receive HDC/SCR adjuvantly.

The South African study (Bezwoda) shows very good results but the discussants at the afternoon session did not have the data made available to them like all the other studies did.  Subsequently, an independent review committee attempted to review the data reported in this study and found that the data had been falsified.  It is our view that, since the principal investigator cheated, this study should simply be thrown out, i.e., no decisions about receiving or not receiving HDC/SCR should be based on ANYTHING reported in this study.

In the Bergh (Swedish) study, the non-treatment arm actually gets much more chemo in six moderately high-adjuvant chemos (non-study arm) than in the treatment arm. The totals are:

Planned total doses per meter squared
 

The second point about the Bergh study was that it was mixed for adjuvant and metastatic treatment which confounds the data and Bergh didn't separate those out.  Finally, if the survival rates are the same, the BMT arm gives a better QOL (because it improves considerably and sooner) than 6 higher dose "regular" cycles.

The problem is that NCI (with some apparent pressure from advocate groups) wanted to release the data at the intermediate analysis point whereas, in Peters' study, the intermediate data were not expected to show any difference in the treatment results. Peters fully expects that there will be a distinct advantage for the treatment arm at 5-6 years. His study actually had only 1/3 of the expected events (deaths/recurrences) to date. But, he also had a higher mortality rate due to the procedure than some other places are getting (City of Hope is one example and they didn't participate in any of these studies because they expected that their own protocols were giving better results -- part of these results were reported in the abstract that I summarized at the beginning of this note).

Uniformly, all of the professional societies that have issued statements about this and that we know about have said that:

• This information basically only represents one more step down the road;
• Patients need to continue to be enrolled in clinical trials;
• Patients not eligible to enroll in clinical trials need to have highly informed consent; and,
• Insurers need to continue covering treatment as they have in the recent past.

The decision to participate in a trial should be a decision made by the patient and her/his physician.

The position of patients with high-risk breast cancer and a consequent high risk of recurrence is one which needs to be seriously considered and which has not been explicitly addressed in the NCI studies.  For these patients, the possibility of reducing their likelihood of recurrence by receiving HDC/SCR is considerable and gives them the possibility of a longer life, possibly without a recurrence of breast cancer.

By continuing to collect data from trials, we will have some firm conclusions one way or the other at some future date.  The patient advocate organizations are split. The ones that don't have high-risk patients involved want this treatment ended for all patients.  The ones that have patients with high-risk breast cancer want the treatment continued within the context of clinical trials.

None of the  material on our website  is intended to provide medical, legal, or psycho-social advice. For those kinds of information, you should contact qualified practitioners in your local area. We do intend to convey our members' experiences with the various procedures involved in cancer treatment from the perspective of the patient to help educate patients and their caregivers.