Real-world data on efficacy and safety of first-line alectinib treatment

Abstract

Plain language summary The advancements in cancer treatment, particularly in the last two decades, have been promising. Non-small-cell lung cancer (NSCLC) is one of the most important diseases experiencing these promising developments. ALK positivity, which is caused by the rearrangement of different gene fragments between two chromosomes, affects about 5% of NSCLC patients. This provides a target for next-generation therapies. One of these targeted therapy drugs is alectinib. The authors examined the outcomes of 271 patients with body-disseminated NSCLC who received alectinib as initial targeted therapy. These patients were not chosen to participate in a clinical phase study. They were treated with an approved drug; the study also included 97 patients who had previously received chemotherapy. The median duration of survival without disease worsening was 26 months for all patients receiving alectinib treatment. This value was 28.8 months in 177 patients who had not received any treatment before alectinib. Regardless of disease status, 77% of all patients were found to be alive at the end of the first year. Alectinib treatment resulted in a significant improvement of the disease in approximately four out of five patients. The treatment's side effects were generally tolerable or manageable. Only four patients were reported to have discontinued their medication due to treatment-related side effects. These real-world findings are compatible with previous clinical research. Alectinib is an important first-line treatment option for patients with advanced, ALK-positive NSCLC.

Aims: In this multicenter study, the authors aimed to determine the real-life efficacy and safety of first-line alectinib. Materials & methods: This retrospective trial included advanced-stage, ALK-positive non-small-cell lung cancer patients who were treated with first-line alectinib in terms of ALK-tyrosine kinase inhibitors, regardless of previous chemotherapy. The co-primary end points were progression-free survival both for all patients and for the treatment-naive population. The secondary end points were overall response rate, overall survival, rate of CNS progression and safety. Results & conclusion: A total of 274 patients (n = 177 for treatment-naive patients) were enrolled in the study. The median progression-free survival was 26 and 28.8 months for all patients and the treatment-naive group, respectively. The overall response rate, CNS progression rate and 1-year overall survival ratio were 77.9, 12.4 and 77%. Alectinib is a highly effective therapy with a favorable safety profile.

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[Paksoy, Nail; Aydiner, Adnan] Istanbul Univ, Dept Med Oncol, Istanbul Fac Med, Istanbul, Turkey.

[Kilickap, Saadettin] Istanbul Univ, Fac Med, Ankara Liv Hosp, Dept Med Oncol, Ankara, Turkey.

[Atci, Muhammed Mustafa; Sakin, Abdullah] Istanbul Prof Cemil Tascioglu City Hosp, Dept Med Oncol, Istanbul, Turkey.

[Kahraman, Seda; Yalcin, Bulent; Nahit Sendur, Mehmet Ali] Yildirim Beyazit Univ, Fac Med, Dept Med Oncol, Ankara, Turkey.

[Keskinkilic, Merve; Oztop, Ilhan] Dokuz Eylul Univ, Fac Med, Dept Med Oncol, Izmir, Turkey.

[Bilgetekin, Irem; Oksuzoglu, Berna] Abdurrahman Yurtaslan Ankara Onkoloji Educ & Res, Dept Med Oncol, Ankara, Turkey.

[Ayhan, Murat] Kartal Dr Lutfi Kirdar City Hosp, Dept Med Oncol, Istanbul, Turkey.

[Tural, Deniz] Bakirkoy Dr Sadi Konuk Educ & Res Hosp, Dept Med Oncol, Istanbul, Turkey.

[Eren, Onder] Selcuk Univ, Fac Med, Dept Med Oncol, Konya, Turkey.

[Akkoc Mustafayev, Fatma Nihan; Ozgun, Mehmet Alpaslan] Univ Hlth Sci, Sultan Abdulhamid Han Educ & Res Hosp 2, Dept Med Oncol, Istanbul, Turkey.

[Tatli, Ali Murat] Akdeniz Univ, Fac Med, Dept Med Oncol, Antalya, Turkey.

[Bayram, Ertugrul] Cukurova Univ, Fac Med, Dept Med Oncol, Adana, Turkey.

[Kutlu, Yasin] Istanbul Medipol Univ, Fac Med, Dept Med Oncol, Istanbul, Turkey.

[Erturk, Ismail] Ankara Gulhane Educ & Res Hosp, Dept Med Oncol, Ankara, Turkey.

[Ozcan, Erkan] Trakya Univ, Fac Med, Dept Med Oncol, Edirne, Turkey.

[Gulmez, Ahmet] Inonu Univ, Fac Med, Dept Med Oncol, Malatya, Turkey.

[Korkmaz, Mustafa] Necmettin Erbakan Univ, Meram Fac Med, Dept Med Oncol, Konya, Turkey.

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[Erdem, Dilek] Samsun Med Pk Hosp, Dept Med Oncol, Samsun, Turkey.

[Telli, Tugba Akin] Marmara Univ, Fac Med, Dept Med Oncol, Istanbul, Turkey.

[Aksoy, Asude] Firat Univ, Fac Med, Dept Med Oncol, Elazig, Turkey.

[Uskent, Necdet] Anadolu Med Ctr, Dept Med Oncol, Kocaeli, Turkey.

[Iriagac, Yakup] Tekirdag Namik Kemal Univ Fac Med, Fac Med, Dept Med Oncol, Tekirdag, Turkey.

[Baytemur, Naziyet Kose] Mem Ankara Hosp, Dept Med Oncol, Ankara, Turkey.

[Aydin, Dincer] Kocaeli Derince Educ & Res Hosp, Dept Med Oncol, Kocaeli, Turkey.

[Sakalar, Teoman] Necip Fazil City Hosp, Dept Med Oncol, Kahramanmaras, Turkey.

[Arak, Haci] Gaziantep Univ, Fac Med, Dept Med Oncol, Gaziantep, Turkey.

[Selcukbiricik, Fatih; Yumuk, Perran Fulden] Koc Univ, Fac Med, Dept Med Oncol, Istanbul, Turkey.

[Ergun, Yakup] Batman Educ & Res Hosp, Dept Med Oncol, Batman, Turkey.

[Korkmaz, Taner] Acibadem Maslak Hosp, Dept Med Oncol, Istanbul, Turkey.

[Ak, Naziye] Yozgat City Hosp, Dept Med Oncol, Yozgat, Turkey.

[Unal, Caglar] Gayrettepe Florence Nightingale Hosp, Dept Med Oncol, Istanbul, Turkey.

[Akdeniz, Nadiye] Adiyaman Univ, Educ & Res Hosp, Dept Med Oncol, Adiyaman, Turkey.

[Algin, Efnan] Univ Hlth Sci, Ankara City Hosp, Dept Med Oncol, Ankara, Turkey.

Amer Hosp, Dept Med Oncol, Istanbul, Turkey.