Sample collection and study design
Patients with lung cancer who visited the authors’ institute’s lung
cancer clinic (Post Graduate Institute of Medical Education and
Research, PGIMER) were included in the current study. The study enrolled
newly diagnosed individuals with histologically or cytologically proven
NSCLC and SCLC for three years. The institute’s ethical committee
approved the study. The inclusion criteria of the lung cancer patients
meeting all the following requirements were eligible for enrollment: (i)
Diagnosis of lung cancer confirmed by cytology or histology (ii) Stage
IIIB - IV or IIIA (not scheduled for surgery). (iii) Untreated and
intent to treat with definitive platinum-based chemotherapy [platinum
agent (Cisplatin or Carboplatin) in combination with either docetaxel,
paclitaxel, gemcitabine, pemetrexed, or irinotecan]. (iv) An Eastern
Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. (v) At
least one bi-dimensionally measurable lesion, according to the RECIST
criteria. (vi) Adequate organ function, defined as absolute neutrophil
count > 1500/µl, platelet count>100,000/µl,
and levels of creatinine, liver enzyme, and alanine aminotransferase
(ALT) less than two times the upper limits of normal (ULN).(vii) Written
informed consent was obtained. The exclusion criteria included (i)
Non-Bronchogenic tumors. (ii) Primary pleural tumors – mesothelioma
(iii) Sarcomas (iv) Metastatic tumors to lungs or pleural (v)
Early-stage (resectable) lung cancer.
All of the participants signed an informed consent form. At the
beginning of this study, the patients had renal function tests, a
complete blood count (CBC), a contrast-enhanced computed tomography (CT)
scan of the thorax (which also encompassed the upper abdomen), liver
function tests, and a chest radiograph. The demographic characteristics
of the participants (gender, age, and performance status), disease
stage, tumor histology, and smoking status were all recorded. CBC was
done tendays after the first chemotherapy session, and any additional
cycles if needed. CBC, renal function, and liver tests were performed
before each treatment cycle and 3-4 weeks following the last
chemotherapy round. The paper was reported using the STROBE checklist.