Local Consolidative Therapy Vs. Maintenance Therapy or Observation for Patients With Oligometastatic Non–Small-Cell Lung Cancer: Long-Term Results of a Multi-Institutional, Phase II, Randomized Study

Abstract

PURPOSE Our previously published findings reported that local consolidative therapy (LCT) with radiotherapy or surgery improved progression-free survival (PFS) and delayed new disease in patients with oligometastatic non–small-cell lung cancer (NSCLC) that did not progress after front-line systemic therapy. Herein, we present the longer-term overall survival (OS) results accompanied by additional secondary end points. PATIENTS AND METHODS This multicenter, randomized, phase II trial enrolled patients with stage IV NSCLC, three or fewer metastases, and no progression at 3 or more months after front-line systemic therapy. Patients were randomly assigned (1:1) to maintenance therapy or observation (MT/O) or to LCT to all active disease sites. The primary end point was PFS; secondary end points were OS, toxicity, and the appearance of new lesions. All analyses were two sided, and P values less than .10 were deemed significant. RESULTS The Data Safety and Monitoring Board recommended early trial closure after 49 patients were randomly assigned because of a significant PFS benefit in the LCT arm. With an updated median follow-up time of 38.8 months (range, 28.3 to 61.4 months), the PFS benefit was durable (median, 14.2 months [95% CI, 7.4 to 23.1 months] with LCT v 4.4 months [95% CI, 2.2 to 8.3 months] with MT/O; P = .022). We also found an OS benefit in the LCT arm (median, 41.2 months [95% CI, 18.9 months to not reached] with LCT v 17.0 months [95% CI, 10.1 to 39.8 months] with MT/O; P = .017). No additional grade 3 or greater toxicities were observed. Survival after progression was longer in the LCT group (37.6 months with LCT v 9.4 months with MT/O; P = .034). Of the 20 patients who experienced progression in the MT/O arm, nine received LCT to all lesions after progression, and the median OS was 17 months (95% CI, 7.8 months to not reached). CONCLUSION In patients with oligometastatic NSCLC that did not progress after front-line systemic therapy, LCT prolonged PFS and OS relative to MT/O.

Effects of oral maintenance chemotherapy and predictive value of circulating EBV DNA in metastatic nasopharyngeal carcinoma

“…In many kinds of cancers, oligometastasis is an independent prognostic factor, including NPC . Some studies have shown that after systemic therapy, patients with oligometastasis can reach more than 5 years of progress‐free survival . Oligometastasis is recognized as an early stage of cancer progression, at which point the invasiveness is still weak, as evidenced by the low number of metastases and a limited number of organs affected .…”

Technology‐driven research for radiotherapy innovation

“…Three randomized controlled trials reported improved overall survival in lung cancer (Gomez et al, 2019) , and a disease agnostic setting ; the fourth study was underpowered for overall survival but reported a significantly improved progression-free survival (Iyengar et al, 2018): The results regarding NSCLC are summarized in Table 1. Whereas radiofrequency ablation was the exclusive locally ablative treatment modality in the earliest CLOCC trial (Ruers et al, 2017), SBRT was the exclusive locally ablative treatment modality in two studies (Iyengar et al, 2018;Palma et al, 2019) and the most frequent in one study (Gomez et al, 2019). Therefore, the current ESMO guideline for oligometastatic NSCLC states that the 'relative contribution of surgery versus radiotherapy as local treatment modality has not been established yet' in OMD.…”

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“…Oligometastatik meme ve prostat kanserinde ortanca sağkalım 36 ayları bulabilmektedir (13,14). Bu durumda metastaz bölgesine küratif amaçlı ablatif RT uygulanır (15).…”