Neoadjuvant chemotherapy and Avelumab in early stage resectable nonsmall cell lung cancer

Abstract Multiple randomized studies have shown that combination of chemotherapy and immune checkpoint inhibitors (ICIs) leads to better response rates and survival as compared to chemotherapy alone in the advanced stage of NSCLC. Data suggesting a benefit to using ICIs in the neoadjuvant therapy of...

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Main Authors: Arafat Tfayli, Majd Al Assaad, Ghina Fakhri, Reem Akel, Hanine Atwi, Hady Ghanem, Fadi El Karak, Fadi Farhat, Kamal Al Rabi, Pierre Sfeir, Pierre Youssef, Ziad Mansour, Hazem Assi, Mohamad Haidar, Alain Abi Ghanem, Ibrahim Khalifeh, Fouad Boulos, Ramy Mahfouz, Bassem Youssef, Youssef Zeidan, Rachelle Bejjany, Fadlo Khuri
Format: Article
Language:English
Published: Wiley 2020-11-01
Series:Cancer Medicine
Subjects:
Online Access:https://doi.org/10.1002/cam4.3456
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author Arafat Tfayli
Majd Al Assaad
Ghina Fakhri
Reem Akel
Hanine Atwi
Hady Ghanem
Fadi El Karak
Fadi Farhat
Kamal Al Rabi
Pierre Sfeir
Pierre Youssef
Ziad Mansour
Hazem Assi
Mohamad Haidar
Alain Abi Ghanem
Ibrahim Khalifeh
Fouad Boulos
Ramy Mahfouz
Bassem Youssef
Youssef Zeidan
Rachelle Bejjany
Fadlo Khuri
author_facet Arafat Tfayli
Majd Al Assaad
Ghina Fakhri
Reem Akel
Hanine Atwi
Hady Ghanem
Fadi El Karak
Fadi Farhat
Kamal Al Rabi
Pierre Sfeir
Pierre Youssef
Ziad Mansour
Hazem Assi
Mohamad Haidar
Alain Abi Ghanem
Ibrahim Khalifeh
Fouad Boulos
Ramy Mahfouz
Bassem Youssef
Youssef Zeidan
Rachelle Bejjany
Fadlo Khuri
author_sort Arafat Tfayli
collection DOAJ
description Abstract Multiple randomized studies have shown that combination of chemotherapy and immune checkpoint inhibitors (ICIs) leads to better response rates and survival as compared to chemotherapy alone in the advanced stage of NSCLC. Data suggesting a benefit to using ICIs in the neoadjuvant therapy of patients with early stage NSCLC are emerging. Eligible subjects were treatment naïve patients with stage IB, II, and resectable IIIA NSCLC. Patients received three cycles of neoadjuvant chemotherapy with four doses of avelumab every 2 weeks. Patients with squamous cell cancer received cisplatin or carboplatin on day 1 and gemcitabine on days 1 and 8 of each cycle of chemotherapy. Patients with nonsquamous histology received cisplatin or carboplatin with pemetrexed on day 1 of each cycle. Patients then proceeded to their planned surgery. Out of 15 patients accrued as part of stage 1 of the study, four had a radiologic response (1 complete response), lower than the minimum of six responses needed to continue to phase 2 of the study. The study was therefore terminated. Majority had adenocarcinoma histology and stage IIIA disease. The treatment was well tolerated with no unexpected side effects. Four patients (26.7%) had grade III/IV CTCAE toxicity. This study confirms that the preoperative administration of chemotherapy and avelumab is safe. There was no indication of increased surgical complications. The benefit of adding immunotherapy to chemotherapy did not appear to enhance the overall response rate of patients in the neoadjuvant setting in patients with resectable NSCLC because this study failed to meet its primary endpoint.
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spelling doaj.art-d6eb58e736a745a1befdf7c504496b672022-12-22T00:45:55ZengWileyCancer Medicine2045-76342020-11-019228406841110.1002/cam4.3456Neoadjuvant chemotherapy and Avelumab in early stage resectable nonsmall cell lung cancerArafat Tfayli0Majd Al Assaad1Ghina Fakhri2Reem Akel3Hanine Atwi4Hady Ghanem5Fadi El Karak6Fadi Farhat7Kamal Al Rabi8Pierre Sfeir9Pierre Youssef10Ziad Mansour11Hazem Assi12Mohamad Haidar13Alain Abi Ghanem14Ibrahim Khalifeh15Fouad Boulos16Ramy Mahfouz17Bassem Youssef18Youssef Zeidan19Rachelle Bejjany20Fadlo Khuri21Division of Hematology‐Oncology American University of Beirut Medical Center Beirut LebanonDivision of Hematology‐Oncology American University of Beirut Medical Center Beirut LebanonDivision of Hematology‐Oncology American University of Beirut Medical Center Beirut LebanonDivision of Hematology‐Oncology American University of Beirut Medical Center Beirut LebanonDivision of Hematology‐Oncology American University of Beirut Medical Center Beirut LebanonDepartment of Internal Medicine Lebanese American University Medical Center‐Rizk Hospital Beirut LebanonDepartment of Internal Medicine Saint Joseph University Beirut LebanonDivision of Hematology‐Oncology Hammoud Hospital University Medical Center Saida LebanonDepartment of Internal Medicine King Hussien Cancer Center Amman JordanDivision of Cardiothoracic Surgery American University of Beirut Medical Center Beirut LebanonDivision of Cardiothoracic Surgery Hammoud Hospital University Medical Center Saida LebanonDivision of Cardiothoracic Surgery Geitaoui Medical Center Beirut LebanonDivision of Hematology‐Oncology American University of Beirut Medical Center Beirut LebanonDepartment of Radiology American University of Beirut Medical Center Beirut LebanonDepartment of Radiology American University of Beirut Medical Center Beirut LebanonDepartment of Pathology American University of Beirut Medical Center Beirut LebanonDepartment of Pathology American University of Beirut Medical Center Beirut LebanonDepartment of Pathology American University of Beirut Medical Center Beirut LebanonDepartment of Radiation Oncology American University of Beirut Medical Center Beirut LebanonDepartment of Radiation Oncology American University of Beirut Medical Center Beirut LebanonDivision of Hematology‐Oncology American University of Beirut Medical Center Beirut LebanonDivision of Hematology‐Oncology American University of Beirut Medical Center Beirut LebanonAbstract Multiple randomized studies have shown that combination of chemotherapy and immune checkpoint inhibitors (ICIs) leads to better response rates and survival as compared to chemotherapy alone in the advanced stage of NSCLC. Data suggesting a benefit to using ICIs in the neoadjuvant therapy of patients with early stage NSCLC are emerging. Eligible subjects were treatment naïve patients with stage IB, II, and resectable IIIA NSCLC. Patients received three cycles of neoadjuvant chemotherapy with four doses of avelumab every 2 weeks. Patients with squamous cell cancer received cisplatin or carboplatin on day 1 and gemcitabine on days 1 and 8 of each cycle of chemotherapy. Patients with nonsquamous histology received cisplatin or carboplatin with pemetrexed on day 1 of each cycle. Patients then proceeded to their planned surgery. Out of 15 patients accrued as part of stage 1 of the study, four had a radiologic response (1 complete response), lower than the minimum of six responses needed to continue to phase 2 of the study. The study was therefore terminated. Majority had adenocarcinoma histology and stage IIIA disease. The treatment was well tolerated with no unexpected side effects. Four patients (26.7%) had grade III/IV CTCAE toxicity. This study confirms that the preoperative administration of chemotherapy and avelumab is safe. There was no indication of increased surgical complications. The benefit of adding immunotherapy to chemotherapy did not appear to enhance the overall response rate of patients in the neoadjuvant setting in patients with resectable NSCLC because this study failed to meet its primary endpoint.https://doi.org/10.1002/cam4.3456immune checkpoint inhibitorsneoadjuvant therapynonsmall cell lung canceroncogenic drivers
spellingShingle Arafat Tfayli
Majd Al Assaad
Ghina Fakhri
Reem Akel
Hanine Atwi
Hady Ghanem
Fadi El Karak
Fadi Farhat
Kamal Al Rabi
Pierre Sfeir
Pierre Youssef
Ziad Mansour
Hazem Assi
Mohamad Haidar
Alain Abi Ghanem
Ibrahim Khalifeh
Fouad Boulos
Ramy Mahfouz
Bassem Youssef
Youssef Zeidan
Rachelle Bejjany
Fadlo Khuri
Neoadjuvant chemotherapy and Avelumab in early stage resectable nonsmall cell lung cancer
Cancer Medicine
immune checkpoint inhibitors
neoadjuvant therapy
nonsmall cell lung cancer
oncogenic drivers
title Neoadjuvant chemotherapy and Avelumab in early stage resectable nonsmall cell lung cancer
title_full Neoadjuvant chemotherapy and Avelumab in early stage resectable nonsmall cell lung cancer
title_fullStr Neoadjuvant chemotherapy and Avelumab in early stage resectable nonsmall cell lung cancer
title_full_unstemmed Neoadjuvant chemotherapy and Avelumab in early stage resectable nonsmall cell lung cancer
title_short Neoadjuvant chemotherapy and Avelumab in early stage resectable nonsmall cell lung cancer
title_sort neoadjuvant chemotherapy and avelumab in early stage resectable nonsmall cell lung cancer
topic immune checkpoint inhibitors
neoadjuvant therapy
nonsmall cell lung cancer
oncogenic drivers
url https://doi.org/10.1002/cam4.3456
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