The Death of Patients Before Receiving Chemotherapy

There is no specific information about the death of patients who died before receiving chemotherapy. Because all the participants had a chronic health problem, it is expected that the article and the appendix provide information about the possible causes of death after enrollment and the general outlook of the participants before enrolment 1 patient in the chemotherapy group died before receiving treatment (appendix page 9)

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It is not specified if the participants who died by the time of data cutoff had disease progression at first or just died in the early stages of disease. 227 patients either died or had disease progression. A total of 96 participants died in the course of study, 47 from crizotinib group and 49 from chemotherapy (article page 2388, 2389 and 2390)

The formula of the hazard ratio of deaths in both groups is not indicated, even in the appendix. It would be better if readers got to know how the hazard ratio was calculated. There needs to be specific information about the control population and the rate of death in the control population compared to the rate of death in the experimental group. The hazard ratio in the crizotinib group was 0.49 for crizotinib group and 1.02 for chemotherapy group (article page 2387 and 2388)

For patients who died of other causes rather than the tumors, the article does not specify whether the causes of their deaths were related to the disease progression or not. A total of 32 participants had died in the course of study due to any cause. 4 from crizotinib group and two from chemotherapy group died due to treatment related causes (article page 2390)

Tumor sizes

In both the article and its appendix, theres no specific information about tumor sizes of the participants. The study did not account for the increase in tumor size in patients with progressing disease. There is no information about the sizes of tumors found in brain or bone metastases. Normally, patients who develop disease progression will have relative increase in the size of the tumor in the original focus or the metastatic area. However, this article did not account for any tumor size in the participants The article and the appendix list the types of tumors found in the participants. The two main types of tumors were adenocarcinoma and non-adenocarcinomas (article page 2388, appendix page 3). It is also indicated that all chemotherapy group participants were given pemetrexed unless their tumors had predominantly squamous cell involvement (article page 2386).

Patients Reported Outcomes and Quality of life

The article and it appendix do not provide the specific measure of global quality of life The global quality of life was over 10 points better among participants on crizotinib than those on chemotherapy (article page 2390)

The symptoms reported in the participants (alopecia, cough, dyspnea, shoulder pain, general pain, neutropenia) can result from other factors rather than lung cancer. The article does not highlight if there were other underlying cause that could determine the pattern of symptoms apart from the treatment There was a significantly overall reduction from baseline in alopecia, cough, dyspnea, chest pain, arm or shoulder pain, fatigue, and pain in other parts of the body with crizotinib than with chemotherapy (article page 2390)

Aminotransferase levels are not specific measures of response to chemotherapy. The article does not provide if there were other confounding factors like liver disease that could influence aminotransferase results 66 patients of any grade of tumor on crizotinib had elevated aminotransferase while 25 patients with any grade of tumor on chemotherapy had elevated aminotransferase levels (article page 2391)