We read with great interest the original paper by Tamiya [1]. We think the conclusion of this trial should be that the primary outcome measure was “met” for the following reasons, even though M. Tamiya et al. concluded that the primary outcome measure was “not met.”
The primary objective of this trial to demonstrate is the “(real) 1-year survival rate is higher than 35% (which means >35%).” The result of this test was that the estimated 1-year survival rate was 58%, and the lower limit of its two-sided 95% confidence interval was 42.9%, which is 35% higher than the set threshold value. Therefore, the test result is p < 0.05 (two-sided), which is statistically significant.
This obviously demonstrated that the “1-year survival rate exceeded 35% in a statistically significant way.” Thus, we believe that the null hypothesis (the 1-year survival rate is 35% or lower) was successfully denied and the data must be interpreted as a positive result in terms of statistics.
Reference
Tamiya M, Tamiya A, Kaneda H, et al. A phase II study of pemetrexed plus carboplatin followed by maintenance pemetrexed as first-line chemotherapy for elderly patients with advanced non-squamous non-small cell lung cancer. Med Oncol. 2016;33:2. doi:10.1007/s12032-015-0715-7.
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Hiroshige Yoshioka received honorarium for lecture from Eli Lilly Japan. Toshihiko Kaneda and Toshihide Yokoyama declare that they have no conflict of interest.
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Yoshioka, H., Kaneda, T. & Yokoyama, T. A statistical issue regarding the original paper by M. Tamiya and others (Med Oncol (2016) 33:2 DOI 10.1007/s12032-015-0715-7). Med Oncol 34, 80 (2017). https://doi.org/10.1007/s12032-017-0942-1
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DOI: https://doi.org/10.1007/s12032-017-0942-1