Anlotinib Combined with S-1 in Third- or Later-Line Stage IV Non-Small Cell Lung Cancer Treatment: A Phase II Clinical Trial.

LESSONS LEARNED: The combination of anlotinib and S-1 exhibited good antitumor activity in third- or later-line treatment for stage IV non-small cell lung cancer (NSCLC). Combination therapy of anlotinib with S-1 has manageable toxicities in patients with NSCLC. BACKGROUND: This study aimed to evaluate the efficacy and safety of anlotinib combined with S-1 as a third- or later-line treatment for patients with stage IV non-small cell lung cancer (NSCLC). Anlotinib was approved in 2018 by the Chinese Food and Drug Administration (FDA) as a third-line treatment for patients with refractory advanced NSCLC and is under study in the U.S. and Europe. METHODS: Simon's phase II clinical trial design with an α error of 5% and a power ß of 80% was used, anticipating a 10% objective response rate (ORR) of anlotinib and a 30% ORR of anlotinib combined with S-1; the required sample size was 29. A total of 29 patients were enrolled in the clinical trial. Patients were treated with anlotinib plus S-1 over a 21-day treatment course until disease progression or unacceptable toxic effects. If the efficacy was assessed as stable disease, partial response, or complete response after six cycles, anlotinib was maintained until disease progression or death. The primary endpoint was the objective response rate. Somatic mutations were not required for study enrollment. RESULTS: The median follow-up time was 11.1 months. Objective responses were observed in 11 of 29 (37.9%) patients making up the intention-to-treat population, which reached the target primary endpoint of 30% ORR. The median overall and progression-free survival were 16.7 and 5.8 months, respectively. The most common grade 3 adverse events (AEs) were gastrointestinal, including nausea, vomiting and diarrhea, fatigue, and hypertension. No grade 4 treatment-related AEs or treatment-related deaths occurred. CONCLUSION: The combination of anlotinib with S-1 in the third- or later-line treatment of stage IV NSCLC shows promising antitumor activity and manageable toxicity in patients with NSCLC; phase III trials will be planned in the future.

Attitudes and behavior of radiation oncologists toward sexual issues of cervical cancer patients who receive radiation therapy: a survey in China.

OBJECTIVE: Cervical cancer is known to impair women's sexual function. This study aimed at investigating the attitudes and behavior of radiation oncologists regarding sexual functioning of female cervical cancer patients who receive radiation therapy. METHODS: A total of 186 radiation oncologists were included. A self-reported questionnaire was used to investigate the attitudes and behavior of radiation oncologists. The oncologists were queried on their history of consultation on sexual issues, attitudes, and behavior toward sexual issues and considerations of sexual life for cervical cancer patients who receive radiotherapy. RESULTS: Among 120 radiation oncologists who completed the questionnaires, 101 (84.2%) had been consulted on sexual issues, of whom only 29 (24.2%) were consulted by more than 10% of cervical cancer patients who received radiation therapy or their families. Compared with those without a history of consultation, radiation oncologists with a history of consultation were more likely to agree that "radiation oncologists should deal with a patient's sexual issues" (88.1% vs 68.4%) and disagree that "sex is private and should not be interfered with" (66.2% vs 44.5%). Five radiation oncologists (4.2%) had received special training to deal with the sexual issues of cervical cancer patients who receive radiotherapy, and 112 oncologists (93.3%) did not have any information on sexual functioning to give the their patients. CONCLUSIONS: History of consultation on sexual issues affects radiation oncologists' attitudes and behavior toward sexual issues of cervical cancer patients. Radiation oncologists should have a more positive attitude toward sexual issues and should receive more specific relevant training.