Background. Prior supplementation with folic acid and vitamin B 12 is required to reduce pemetrexed therapy toxicity; the recommended lead-in time is at least 7 days. On the basis of previous pharmacokinetic and clinical studies, we hypothesized that the lead-in time could be shortened to 24 hours, enabling earlier commencement of standard chemotherapy; thus, we planned the first prospective trial of this regimen. Methods. Patients with advanced nonsquamous non-small cell lung cancer who had not previously received cytotoxic chemotherapy were enrolled. After measurement of homocysteine concentrations, the patients received 1,000 mg of vitamin B 12 by intramuscular injection and began taking 350-500 mg of oral folic acid daily. Starting 24-48 hours after the vitamin B 12 injection, the patients received intravenous 500 mg/m 2 pemetrexed and 75 mg/m 2 cisplatin for 4 cycles at 3

This study failed to meet its primary endpoint. We could not demonstrate the safety and efficacy of the 1-week vitamin B12 oral administration protocol as compared with intramuscular administration.

UMIN-CTR identifier: UMIN000010738.

BackgroundThe role of irinotecan for elderly patients with LD-SCLC has been unclear, and the timing of TRT combined with chemotherapy has not been fully evaluated.MethodsPatients aged > 70 years with untreated, measurable, LD-SCLC, performance status (PS) 0–2, and adequate organ function were eligible. Treatment consisted of induction with carboplatin on day 1 and irinotecan on days 1 and 8, every 21 days for 4 cycles, and sequential TRT (54Gy in 27 fractions). Carboplatin doses were based on AUC of 4 and 5 (levels 1 and 2, respectively), with a fixed irinotecan dose (50 mg/m2). Primary objective of the phase II study was overall responce rate. ResultsForty-three patients were enrolled and forty-one were finally analyzed (median age: 75 years [range 70–86 years); males 31; PS 0/1/2, n = 22/18/1]. Two patients were excluded because of protocol violation (ascertained to be extensive disease). Twelve patients were accrued at phase I and the number of patients with carboplatin dose-limiting toxicities at levels-1 (n = 6) and −2 (n = 6) were 1(grade 3 hypertension) and 2 (grade 4 thrombocytopenia), respectively. The phase II trial was expanded to 29 additional patients receiving the level 1 carboplatin dose, total of 35 patients. The median number of chemotherapy cycles was 4 (range 1–4), and the median radiation dose was 54Gy (range 36–60). Toxicities were generally mild. There were 4 complete and 27 partial responses (response rate 88.6%). With a median follow-up of 52 months, the median progression-free and overall survival times of phase II were 11.2 and 27.1 months, respectively.ConclusionsInduction chemotherapy of carboplatin plus irinotecan and sequential TRT was well tolerated and effective for elderly patients with LD-SCLC. Additional confirmatory studies are warranted.Trial registrationTrial registration number: UMIN000007352 Name of registry: UMIN.Date of registration: 1/Dec/2006.Date of enrolment of the first participant to the trial: 6/Feb/2007.Clinical trial registration date: 1/Feb/2006 (prospective).Electronic supplementary materialThe online version of this article (doi:10.1186/s12885-017-3353-y) contains supplementary material, which is available to authorized users.

Thymic carcinoma is a rare cancer, accounting for only 1% to 4% of thymic epithelial tumors. Endobronchial metastasis is a rare presentation of these tumors. A 64-year-old man presented with a cough. Lung cancer was suspected because a chest radiograph showed a 7-cm mass in the left pulmonary hilum. Computed tomography showed a mass in the anterior mediastinum and an infiltrate in the upper lobe of the left lung. Bronchoscopy demonstrated bilateral polypoid tumors in the left B bronchus and the right B bronchus. Endobronchial biopsies of both lesions resulted in a diagnosis of squamous cell carcinoma that was positive for c-KIT by immunohistochemical staining. The patient was eventually found to have thymic squamous cell carcinoma with bilateral endobronchial metastases (stage IVb according to the Masaoka-Koga staging system) by diagnostic video-assisted thoracoscopic surgery. He was subsequently treated with platinum-doublet chemotherapy and achieved a partial response for 18.8 months.