Background: The role of 18 fludeoxyglucose ( 18 F-FDG) PET/CT in the management of limited stage small-cell lung cancer (LS-SCLC) is uncertain. Previous studies have shown that 18 F-FDG PET/CT upstages up to 30% of LS-SCLC patients. Data from the CONVERT trial was analysed to investigate the impact of 18 F-FDG PET/CT in the management of LS-SCLC. The prognostic significance of pre-treatment 18 F-FDG PET parameters was also investigated in an exploratory analysis. Method: CONVERT is an international multi-centre phase III trial that randomly assigned fit patients to receive either twice-daily (45Gy in 30 fractions) or once-daily (66Gy in 33 fractions) radiotherapy starting on day 22 of chemotherapy cycle 1 (NCT00433563). Chemotherapy consisted of 4-6 cycles of cisplatin and etoposide. Prophylactic cranial irradiation was offered, if indicated. Contrast-enhanced thorax and abdomen CT and brain imaging (with/ without bone scintigraphy according to clinical indication) were mandated for all CONVERT participants (conventional imaging). Staging with 18 F-FDG PET/CT was allowed but not mandated. The primary endpoint was overall survival. Pre-treatment 18 F-FDG PET metabolic parameters were investigated in a subset of patients (n¼96) including standardised uptake values (max, mean and peak), volumetric and heterogeneity parameters. Result: Of 547 patients recruited to CONVERT, 540 patients with data on staging investigations and outcome were included in this analysis. The use of staging 18 F-FDG PET/CT was variable in the 8 countries recruiting to CONVERT (range, 41-100%). Compared to patients who underwent conventional imaging (n¼231), patients who were also staged with 18 F-FDG PET/CT (n¼309) had smaller gross tumour volume (p¼0$003), were less likely to have elevated pre-treatment serum lactate dehydrogenase (p¼0$035), and received more chemotherapy cycles (p¼0$026). There were no other significant differences in baseline and treatment characteristics between the two groups. There were no significant differences in overall (hazard ratio 0$87 [95% CI 0$70-1$08]; p¼0$192) and progression-free survival (hazard ratio 0$87 [95% CI 0$71-1$07]; p¼0$198) between patients staged with 18 F-FDG PET/CT in addition to conventional imaging or with conventional imaging alone. These results were observed irrespective of treatment group (once-daily and twice-daily radiotherapy). Pre-treatment 18 F-FDG PET parameters were also not prognostic. Conclusion: In CONVERT, survival outcomes were not different in LS-SCLC patients staged with or without 18 F-FDG PET/CT. This was despite those patients staged with 18 F-PET/CT having more favourable baseline and treatment characteristics. Our findings suggest that conventional imaging is sufficient to select LS-SCLC patients for concurrent chemoradiotherapy.Background: The interim analysis of our prospective trial, which compared irradiation to pre-chemotherapy or post-chemotherapy tumour extent while application of involved field radiotherapy (IFRT) for limited-stage small cell lung cancer (SCLC...
The most recent version of the European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for the diagnosis, treatment and follow-up of early and locally-advanced non-small-cell lung cancer (NSCLC) was published in 2017, and covered the diagnosis, staging, management and treatment of both early stage I and II disease and locally-advanced stage III disease. At the ESMO Asia Meeting in November 2018, it was decided by both the ESMO and the Korean Society of Medical Oncology (KSMO) to convene a special face-to-face guidelines meeting in 2019 in Seoul. The aim was to adapt the ESMO 2017 guidelines to take into account potential differences related to ethnicity, cancer biology and standard practices associated with the treatment of locally-advanced, unresectable NSCLC in Asian patients. These guidelines represent the consensus opinions reached by those experts in the treatment of patients with lung cancer who represented the oncology societies of Korea (KSMO), China (CSCO), India (ISMPO), Japan (JSMO), Malaysia (MOS), Singapore (SSO) and Taiwan (TOS). The voting was based on scientific evidence, and it was independent of both local current treatment practices and the treatment availability and reimbursement situations in the individual participating Asian countries.
Conclusions: Tislelizumab plus chemotherapy was generally well tolerated and demonstrated antitumor activity in pts with nsq-NSCLC.Clinical trial identification: NCT03663205.
Background: Ceritinib is a highly selective ALK inhibitor that has been shown potent antitumor activity against ALK-positive nonsmall cell lung cancer (NSCLC). We conducted a multicenter singlearm phase II study to assess the efficacy and safety of neoadjuvant therapy with ceritinib followed by surgery in patients with ALKpositive resectable locally advanced (LA) NSCLC. Method: Three cycles of ceritinib were administered as induction therapy. The drug was administered orally at the dose 750 mg once daily for 28 days per cycle. The primary endpoint was the major pathological response rate (mpRR). This study required 19 patients, with mpRR of 15% considered non-promising and 45% promising (one-side alpha ¼ 0.025; beta ¼ 0.2). Biomarker analyses using pre-and postceritinib through next-generation sequencing (NGS) of plasma and tissue is also planned. (Trial Identifier, UMIN000017906). Result: A total of 395 patients with LA-NSCLC were screened from March 2015 to March 2018 and 15 patients (4%) were identified as ALKpositive. Only 7 patients were enrolled because of slow accrual. The median age of the patients was 50 years and 71% (n¼5) were male. All patients had stage IIIA disease and adenocarcinoma. 6 out of 7 patients completed three cycles of neoadjuvant therapy with ceritinib as planned, 71% (n¼5) of patients required dose adjustment. One patient was withdrawn from the study because of hepatitis. The objective clinical response rate was 100%. Surgical resection was performed in 6 patients, and complete (R0) resection was achieved in 5 patients. Among the 7 evaluable patients, the mpRR was 57% (95% CI, 18 to 90); 4 patients achieved mpR and 2 patients achieved pathologic complete response. With a median follow-up of 10 (range 8-33) months, 1 patient died of disease progression and 6 patients remain alive, including 4 patients who are recurrence-free. The most common toxicities were gastrointestinal toxicities. Conclusion: Our results showed that neoadjuvant ceritinib is safe and effective, with a high rate of pathologic response, in patients with ALK-positive resectable LA-NSCLC, although the limitation of the data interpretation due to small sample size.
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