Novartis Oncology misses again

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Anonymous

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Here is the latest disappointment for the OBU.

The New England Journal of Medicine
original article
Breast-Cancer Adjuvant Therapy with Zoledronic Acid

Background

Data suggest that the adjuvant use of bisphosphonates reduces rates of recurrence and death in patients with early-stage breast cancer. We conducted a study to determine whether treatment with zoledronic acid, in addition to standard adjuvant therapy, would improve disease outcomes in such patients.

Results

...there was no significant between-group difference in the primary end point, with a rate of disease-free survival of 77% in each group (adjusted hazard ratio in the zoledronic acid group, 0.98; 95% confidence interval [CI], 0.85 to 1.13; P=0.79). Disease recurrence or death occurred in 377 patients in the zoledronic acid group and 375 of those in the control group. In the zoledronic acid group, there were 17 confirmed cases of osteonecrosis of the jaw (cumulative incidence, 1.1%; 95% CI, 0.6 to 1.7; P<0.001) and 9 suspected cases; there were no cases in the control group. Rates of other adverse effects were similar in the two study groups.

Conclusions

These findings do not support the routine use of zoledronic acid in the adjuvant management of breast cancer. (Funded by Novartis Pharmaceuticals and the National Cancer Research Network; AZURE Current Controlled Trials number, ISRCTN79831382.)
 












dont miss the subtly that it is the "adjusted" hazard ratio of 0.98.

The Novartis playbook includes master of statistical magic to spin the numbers in their favor.

Guess what the unadjusted hazard ratio is?
 












Anonymous said:
dont miss the subtly that it is the "adjusted" hazard ratio of 0.98.

The Novartis playbook includes master of statistical magic to spin the numbers in their favor.

Guess what the unadjusted hazard ratio is?
Click to expand...


Quote from the abstract
"...adjusted hazard ratio in the zoledronic acid group, 0.98; 95% confidence interval [CI], 0.85 to 1.13; P=0.79). Disease recurrence or death occurred in 377 patients in the zoledronic acid group and 375 of those in the control group."

The unadjusted HR is not so important here as the observation that there was no therapeutic difference. Since the confidence straddles 1 there can be no statistical significance (p=0.79) Add to this the fact that there was a 1.1% incidence of ONJ with Zoledronic Acid and 0 in the control group and it leaves you with a situation where there is morbidity in the treatment arm that is not offset by any benefit!
 












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