UMIN-CTR Clinical Trial

The results indicate that a history or presence of other types of cancer might be a major deci-sive factor for surgery. Patients with c-stages I and II (c-T2N1) can be considered for surgery, and PCI maybe useful in patients undergoing surgery in a practical setting, partly supporting the ESMO guidelines.

The median age was 70 years, 34 patients were female, and 12 were never smokers. The median maximum tumor diameter was 20 mm.Ninety-six patients  received either a positron emissiontomography scan or PET-chest tomography  for exam-ination at the clinical stage. Most of the cases were c-stage IA. Three patients at p-stage IV had received systemic examination before surgery. One patient diagnosed with M1a had slight ipsilateral pleural effusion, of which the amountwas not enough for thoracentesis. Another patient diagnosed withM1a had ipsilateral pleural nodules, which had not been detectedby CT scan before surgery. One patient diagnosed with M1b hadsuffered from lumbago before surgery; however, bone scintigraphy demonstrated no signs for corresponding lesions. He did notreceive PET scan. His symptom got worse after surgery, and a lum-bar MRI revealed bone metastasis. Fifty-one patients (32.7%) had ahistory or presence of other types of cancer. Preoperative diagnosisof cancer was achieved in 82 (52.6%) patients. Combined SCLC wasdefined as the multiphasic malignant lung tumors containing anyproportion of SCLC cells according to the 2004 World Health Organization classification. The diagnoses of pure and combined SCLC were determined by the central pathological review board,and the number of patients in the two groups was 113 and 43 , respectively. The majority of the patients underwentlobectomy along with systematic mediastinal lymph nodedissection. Adjuvant chemotherapy, including chemora-diotherapy was conducted in 100  patients, of whom 13 received postoperative radiotherapy and four also underwent neo-adjuvant chemotherapy. Ninety-three patients receivedplatinum doublet. Thirteen patients received perioperative prophylacticcranial irradiation (PCI). Most of the 13 patients received either 25 Gray /10fractions or 30 Gy/15 fr. The median age of the patients undergo-ing PCI was 70 years, and the median follow-up timefrom PCI was 35.7 months . All 13 patients underwent adjuvant chemotherapy before PCI. Two of these patientsreceived neoadjuvant chemoradiotherapy followed by PCI beforesurgery. The median time to PCI from the date of surgery for theremaining 11 patients who received postoperative PCI was 5.7months. Recurrence was identified in four patients,one of whom had brain metastasis, 7.7 months after PCI with adose of 10 Gy/5 fr. According to the medical records, no treatment-related deteriorations, such as communication deficit, weakness oflegs, intellectual deficit, and memory loss were observed in any ofthe patients during the follow-up time.

Our eligibility criteria included patients with primary SCLCwho had undergone complete surgical resection of the primarylung tumor from January 2003 through January 2013 at institu-tions participating in either the Fukushima Investigative Group forHealing Thoracic Malignancy (FIGHT) or the Hokkaido Lung Can-cer Clinical Study Group Trial (HOT). Written informed consentwas obtained only from patients who were still alive at the timeof data accrual (from February 2013 through January 2014). Thestudy was registered with the University Hospital Medical Informa-tion Network (UMIN) Clinical Trials Registry, identification numberUMIN000010116, and approved by the Institutional Review Boardof each participating institution. All individual data were obtainedfrom medical records and de-identified. Stages were determinedor reclassified according to the seventh version of the tumor-node-metastasis (TNM) staging system. In the case of patients whounderwent either neo-adjuvant chemotherapy or neo-adjuvantchemoradiotherapy, c-stage was defined as the stage before thosetherapies.

not available

Clinical variables that determine overall survival