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NADIM trial: neoadjuvant chemotherapy and Nivolumab in resectable non-small-cell lung cancer


Non-small-cell lung cancer ( NSCLC ) is terminal in most patients with locally advanced stage disease.

Researchers have assessed the antitumour activity and safety of neoadjuvant chemoimmunotherapy for resectable stage IIIA NSCLC in an open-label, multicentre, single-arm phase 2 trial done at 18 hospitals in Spain.
Eligible patients were aged 18 years or older with histologically or cytologically documented treatment-naive American Joint Committee on Cancer (AJCC )-defined stage IIIA NSCLC that was deemed locally to be surgically resectable by a multidisciplinary clinical team, and an ECOG performance status of 0 or 1.

Patients received neoadjuvant treatment with intravenous Paclitaxel ( 200 mg/m² ) and Carboplatin ( area under curve 6; 6 mg/mL per min ) plus Nivolumab ( Opdivo ) ( 360 mg ) on day 1 of each 21-day cycle, for three cycles before surgical resection, followed by adjuvant intravenous Nivolumab monotherapy for 1 year ( 240 mg every 2 weeks for 4 months, followed by 480 mg every 4 weeks for 8 months ).

The primary endpoint was progression-free survival at 24 months, assessed in the modified intention-to-treat population, which included all patients who received neoadjuvant treatment, and in the per-protocol population, which included all patients who had tumour resection and received at least one cycle of adjuvant treatment.
Safety was assessed in the modified intention-to-treat population.

In the period 2017-2018, researchers screened 51 patients for eligibility, of whom 46 patients were enrolled and received neoadjuvant treatment.

At the time of data cutoff ( Jan 31, 2020 ), the median duration of follow-up was 24·0 months ( IQR 21.4–28.1 ) and 35 of 41 patients who had tumour resection were progression free.

At 24 months, progression-free survival was 77.1% ( 95% CI, 59.9 - 87.7 ).

43 ( 93% ) of 46 patients had treatment-related adverse events during neoadjuvant treatment, and 14 ( 30% ) had treatment-related adverse events of grade 3 or worse; however, none of the adverse events were associated with surgery delays or deaths.
The most common grade 3 or worse treatment-related adverse events were increased lipase ( 3 [ 7% ] ) and febrile neutropenia ( 3 [ 7% ] ).

The results support the addition of neoadjuvant Nivolumab to Platinum-based chemotherapy in patients with resectable stage IIIA non-small-cell lung cancer.
Neoadjuvant chemoimmunotherapy could change the perception of locally advanced lung cancer as a potentially lethal disease to one that is curable. ( Xagena )

Provencio M et al, Lancet Oncol 2020; 21: 1413-1422

XagenaMedicine_2020



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