The European Society of Medical Oncology this year saw many studies and trials presented on research and development in head and neck and lung cancer. Here, Dr. Vishwanath Sathyanarayan provides takeaways and abstracts of studies that hold prominence in India.

Head and Neck Cancer

Phase III KEYNOTE-048 trial

The study looked at pembrolizumab, a PD-1 blocker as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This was a phase 3, randomised trial conducted in 882 patients in which pembrolizumab was combined with a platinum plus 5-flurouracil (5-FU) as compared with cetuximab with platinum chemotherapy plus 5-FU (the EXTREME regimen), the current standard of care for first-line HNSCC treatment. The primary endpoints were overall survival and progression-free survival.

Findings:

1. In patients expressing PD-L1, the overall survival was significantly longer with pembrolizumab (14.9 months) in comparison with the standard regimen (10.7 months, hazard ratio [HR] 0.61, p=0.0007). However, there was no difference in progression-free survival between groups.
2. In the subset analysis, the overall survival was better with pembrolizumab even in the sub-groups which had a PD-L1 >1%.

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Cetuximab vs. cisplatin for HPV-positive oropharyngeal cancer

Mehanna and colleagues compared cetuximab vs. cisplatin as a radiation sensitiser in patients with Human Papilloma Virus (HPV)-positive, low-risk oropharyngeal cancer, receiving radical radiotherapy. Overall survival with the 2 treatments (radiotherapy and either cisplatin or cetuximab) was compared in 334 patients with HPV-positive oropharyngeal cancer.

Finding: Patients on cisplatin had a significantly higher 2-year overall survival rate (97.5%) than those on cetuximab (89.4%; P = .001, hazard ratio [HR] = 4.99, 95% confidence interval [CI] = 1.70–14.67).

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Lung Cancer

IMpower 130 trial

Results from the phase 3 trial involving 723 patients were presented by Cappuzzo et al., at ESMO 2018. It showed that adding the PD-L1 blocker atezolizumab to carboplatin plus nab-paclitaxel followed by atezolizumab maintenance in the first-line therapy for stage IV non- squamous non-small cell lung cancer significantly improved progression-free survival (PFS) and overall survival (OS) as compared to the chemotherapy arm of nab-paclitaxel with carboplatin.

Findings:

1. There was a 4.7 months and 1.5 months median OS and PFS advantage respectively with this regimen.
2. PFS and OS benefits were observed in all PD-L1 subgroups and were observed in all subgroups except those with liver metastases.

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ASCEND-3 study

The updated results of the ASCEND-3, a phase 2 trial was presented by Felip et al. ALKi-naïve patients (aged, ≥18 years) with locally advanced or metastatic ALK+ NSCLC, who had received ≤3 lines of chemotherapy were included. In the 124 ceritinib-treated patients, 40% had baseline brain metastases. Median follow-up time was 52.14 months (range, 48.4-60.1).

Finding: The ORR was 84%, median PFS was 16.6 months and OS was 51.3 months respectively. (95% CI: 42.7, 55.3).

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CTONG 1103 trial

Zhong et al., presented the results of CTONG 1103 trial in which 386 patients with stage IIIA (N2 disease) NSCLC with EGFR mutation positivity were randomly assigned in 1:1 ratio to erlotinib for 42 days as neoadjuvant therapy and then for 12 months after surgery or gemcitabine with carboplatin group for 2 cycles neoadjuvant chemotherapy and 2 cycles after complete resection.

Findings:

1. The ORR, lymph node downstaging and major pathological response were longer in the erlotinib arm.
2. The median PFS was also significantly longer with erlotinib (21·5 months; 95% CI, 19·3–23·6) versus GC (11·9 months; 95% CI, 9·1–14·7; HR 0·42; 95% CI, 0·23–0·76; p=0·003).

 

Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.

The writer, Dr. Vishwanath Sathyanarayan is a Medical Oncologist from Apollo Hospitals, Bangalore with a fellowship from MD Anderson Cancer Center.