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Background: The effect of adding local ablative radiotherapy on oligo‐progression while continuing EGFR‐TKIs in advanced non–small cell Lung cancer (NSCLC) patients is to be determined. Methods: Outcomes of patients with stage IV NSCLC harboring EGFR‐activating mutations having ≤5 sites of oligo‐progression while on EGFR‐TKIs and given one to eight fractions of local ablative radiotherapy (LAR) were reviewed from 2012 to 2019. The time of starting first‐line EGFR‐TKIs to LAR is defined as progression‐free survival 1 (PFS1; > one line of prior treatment allowed). The primary endpoint was PFS from LAR to further progression that led to stop of EGFR‐TKIs (PFS2). The secondary endpoint was overall survival from LAR (OS). Factors affecting PFS2 and OS were analyzed with Cox regression. Results: There were total 55 eligible patients. The median follow‐up time was 13.3 months. Majority (89%) had sensitive mutations (exon 19 deletion and exon 21 L858R mutation). Total number of lesions treated were 75, including lung (n = 45), bone (n = 15), cervical lymph node (n = 1), adrenal (n = 1), and brain (n = 13). The median PFS2 was 6.9 months. The median OS was 25.1 months. On multivariable analysis, it was found that EGFR mutation type (exon 19 deletion / exon 21 L858R mutation vs. other rarer mutations), time from diagnosis to LAR within 70 days, and fewer lines of prior TKIs (1 or 2 vs. 3) had favorable effect on PFS2 (p = 0.006/0.00003; 0.046; 0.001/0.005, respectively). Conclusion: LAR is a noninvasive and effective modality in treatment of oligo‐progressive diseases for patients with EGFR mutations positive NSCLC while on EGFR‐TKIs. [ABSTRACT FROM AUTHOR]

Aim: The significance and prioritization of early phase oncology trial continuation during a global pandemic is unknown. This study reported the outcomes, multiple challenges, and broad recommendations associated with the impact of the novel coronavirus disease 2019 (COVID‐19) on oncology early phase 1 trials—and on drug development in Asia—based on the experiences and perspectives of Asian oncology phase 1 centers. Methods: Between March and April 2020 during the initial period of outbreak, the impact of COVID‐19 across oncology phase 1 sites in five Asian countries—China (Hong Kong), Japan, South Korea, Taiwan, and Singapore—was retrospectively analyzed. Results: There was no trial termination or treatment discontinuation in all five countries. Although the most common impact was new patient enrollment being placed on hold, which was based on pharmaceutical sponsors' decision‐making, the situation varied per site. Most sites had no restrictions in place that would limit their ability to fully comply with the requirements of conducting the early phase studies. The number of protocol deviations during the pandemic was largely dependent on domestic transportation status during the outbreak rather than the ability of the clinical trial centers. Conclusion: Determining the risk to benefits ratio of patients with cancer who are enrolled in early phase 1 clinical trials under the unusual circumstances of a global pandemic is important. Specific guidance or guidelines on the conduct of early phase 1 clinical trials during public health emergencies that are based on the recent lessons learned is urgently required. [ABSTRACT FROM AUTHOR]