PMID- 38489861
OWN - NLM
STAT- MEDLINE
DCOM- 20240422
LR  - 20240422
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 202
DP  - 2024 May
TI  - Real-world outcomes of Italian patients with advanced non-squamous lung cancer 
      treated with first-line pembrolizumab plus platinum-pemetrexed.
PG  - 114006
LID - S0959-8049(24)00162-X [pii]
LID - 10.1016/j.ejca.2024.114006 [doi]
AB  - PURPOSE: The aim of this multi-center, retrospective/prospective cohort 
      observational study was to evaluate outcomes in routine clinical practice of 
      first-line chemo-immunotherapy with cis/carboplatin, pemetrexed and pembrolizumab 
      in patients with advanced non-squamous non-small cell lung cancer (NSCLC) in 33 
      Italian centers. METHODS: The outcome measure was to evaluate overall survival 
      (OS) in a real-world patient population. Secondary endpoints were: 
      progression-free survival (PFS), objective response rate (ORR), duration of 
      response (DoR) and incidence of treatment-related adverse events (AEs). RESULTS: 
      1068 patients were enrolled at the time of data cut-off (January 31st, 2023), and 
      812 (76.0%) belonged to the retrospective cohort. Median age was 66 years 
      (27-85), ECOG PS was >/= 2 in 91 (8.6%) patients; 254 (23.8%) patients had brain 
      metastases at baseline; 38 (3.6%) patients had tumor with PD-L1 expression >/= 50%. 
      After a median follow-up of 17.0 months (95% CI, 16.1-17.9), median OS was 16.1 
      months (95% CI, 14.4-18.8) and PFS was 9.9 months (95% CI, 8.8-11.2). Median DoR 
      (n = 493) was 14.7 months (95% CI, 13.6-17.1). ORR was 43.4% (95% CI, 40.4-46.4). 
      Any-grade AEs occurred in 636 (59.6%) patients and grade >/= 3 in 253 (23.7%) 
      patients. Most common grade >/= 3 AEs were neutropenia (6.3%) and anemia (6.3%). 
      CONCLUSIONS: First-line chemo-immunotherapy was effective and tolerable in this 
      large, real-world Italian study of patients with advanced non-squamous NSCLC. Our 
      results were in line with the KEYNOTE-189 registration study, also considering 
      the low number of PD-L1 >/= 50% patients included in our study.
CI  - Copyright (c) 2024 Elsevier Ltd. All rights reserved.
FAU - Leonetti, Alessandro
AU  - Leonetti A
AD  - Medical Oncology Unit, University Hospital of Parma, Parma, Italy.
FAU - Perrone, Fabiana
AU  - Perrone F
AD  - Medical Oncology Unit, University Hospital of Parma, Parma, Italy. Electronic 
      address: fperrone@ao.pr.it.
FAU - Puntoni, Matteo
AU  - Puntoni M
AD  - Clinical & Epidemiological Research Unit, University Hospital of Parma, Parma, 
      Italy.
FAU - Maglietta, Giuseppe
AU  - Maglietta G
AD  - Clinical & Epidemiological Research Unit, University Hospital of Parma, Parma, 
      Italy.
FAU - Bordi, Paola
AU  - Bordi P
AD  - Medical Oncology Unit, University Hospital of Parma, Parma, Italy.
FAU - Bria, Emilio
AU  - Bria E
AD  - UOSD Oncologia Toraco-Polmonare, Comprehensive Cancer Center, Fondazione 
      Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; Medical Oncology, 
      Department of Traslational Medicine and Surgery, Universita Cattolica del Sacro 
      Cuore, Rome, Italy.
FAU - Vita, Emanuele
AU  - Vita E
AD  - UOSD Oncologia Toraco-Polmonare, Comprehensive Cancer Center, Fondazione 
      Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; Medical Oncology, 
      Department of Traslational Medicine and Surgery, Universita Cattolica del Sacro 
      Cuore, Rome, Italy.
FAU - Gelsomino, Francesco
AU  - Gelsomino F
AD  - Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 
      Italy.
FAU - De Giglio, Andrea
AU  - De Giglio A
AD  - Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, 
      Italy.
FAU - Gelibter, Alain
AU  - Gelibter A
AD  - Medical Oncology (B), Policlinico Umberto I, "Sapienza" University of Rome, Rome, 
      Italy.
FAU - Siringo, Marco
AU  - Siringo M
AD  - Medical Oncology (B), Policlinico Umberto I, "Sapienza" University of Rome, Rome, 
      Italy.
FAU - Mazzoni, Francesca
AU  - Mazzoni F
AD  - Medical Oncology Unit, Careggi University Hospital, Florence, Italy.
FAU - Caliman, Enrico
AU  - Caliman E
AD  - Medical Oncology Unit, Careggi University Hospital, Florence, Italy.
FAU - Genova, Carlo
AU  - Genova C
AD  - Academic Oncology Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy; 
      Department of Internal Medicine and Medical Specialties, University of Genoa, 
      Genoa, Italy.
FAU - Bertolini, Federica
AU  - Bertolini F
AD  - Division of Medical Oncology, Azienda Ospedaliero-Universitaria Policlinico, 
      Modena, Italy.
FAU - Guaitoli, Giorgia
AU  - Guaitoli G
AD  - Division of Medical Oncology, Azienda Ospedaliero-Universitaria Policlinico, 
      Modena, Italy.
FAU - Passiglia, Francesco
AU  - Passiglia F
AD  - Department of Oncology, University of Turin, AOU San Luigi Gonzaga, Orbassano, 
      Turin, Italy.
FAU - Delcuratolo, Marco Donatello
AU  - Delcuratolo MD
AD  - Department of Oncology, University of Turin, AOU San Luigi Gonzaga, Orbassano, 
      Turin, Italy.
FAU - Montrone, Michele
AU  - Montrone M
AD  - Medical Thoracic Oncology Unit, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, 
      Italy.
FAU - Cerea, Giulio
AU  - Cerea G
AD  - Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy.
FAU - Pasello, Giulia
AU  - Pasello G
AD  - Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Padua, Italy; Department of 
      Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.
FAU - Roca, Elisa
AU  - Roca E
AD  - Thoracic Oncology - Lung Unit, Pederzoli Hospital, Peschiera del Garda, Italy.
FAU - Belluomini, Lorenzo
AU  - Belluomini L
AD  - Medical Oncology, Department of Medicine, University of Verona Hospital Trust, 
      Verona, Italy.
FAU - Cecere, Fabiana Letizia
AU  - Cecere FL
AD  - Oncology 1, Regina Elena National Cancer Institute IRCCS Rome, Rome, Italy.
FAU - Guida, Annalisa
AU  - Guida A
AD  - Department of Medical Oncology, St. Mary's Hospital, Terni, Italy.
FAU - Manzo, Anna
AU  - Manzo A
AD  - Thoracic Medical Oncology, Istituto Nazionale Tumori IRCCS "Fondazione G. 
      Pascale", Naples, Italy.
FAU - Adamo, Vincenzo
AU  - Adamo V
AD  - Medical Oncology Unit, Azienda Ospedaliera Papardo, Messina, Italy.
FAU - Rastelli, Francesca
AU  - Rastelli F
AD  - Medical Oncology, AST (Azienda Sanitaria Territoriale) of Ascoli Piceno, Ascoli 
      Piceno, Italy.
FAU - Bulotta, Alessandra
AU  - Bulotta A
AD  - Department of Oncology, Istituto di Ricerca a Carattere Scientifico (IRCCS) San 
      Raffaele Hospital, Milan, Italy.
FAU - Citarella, Fabrizio
AU  - Citarella F
AD  - Department of Medical Oncology, Campus Bio-Medico University, Rome, Italy.
FAU - Toschi, Luca
AU  - Toschi L
AD  - IRCCS Humanitas Clinical and Research Center - Humanitas Cancer Center, Rozzano, 
      Milan, Italy.
FAU - Zoratto, Federica
AU  - Zoratto F
AD  - Medical Oncology, Santa Maria Goretti Hospital, Latina, Italy.
FAU - Cortinovis, Diego Luigi
AU  - Cortinovis DL
AD  - SC Medical Oncology, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy; 
      Medicine and Surgery Department, University of Milano Bicocca, Milan, Italy.
FAU - Berardi, Rossana
AU  - Berardi R
AD  - Oncology Clinic, Universita Politecnica Delle Marche, Ospedali Riuniti Di Ancona, 
      Ancona, Italy.
FAU - Follador, Alessandro
AU  - Follador A
AD  - Medical Oncology Unit San Daniele - Tolmezzo, ASUFC Azienda Sanitaria 
      Universitaria Friuli Centrale, Italy.
FAU - Carta, Annamaria
AU  - Carta A
AD  - Pathology and Oncology Unit, Businco Oncological Hospital, Cagliari, Italy.
FAU - Camerini, Andrea
AU  - Camerini A
AD  - Medical Oncology, Versilia Hospital, Azienda USL Toscana Nord Ovest, Lido di 
      Camaiore, Italy.
FAU - Salerno, Flavio
AU  - Salerno F
AD  - Department of Oncology, University of Turin, Ordine Mauriziano Hospital, Turin, 
      Italy.
FAU - Silva, Rosa Rita
AU  - Silva RR
AD  - Department of Oncology, ASUR Marche, Area Vasta 2, Fabriano, Italy.
FAU - Baldini, Editta
AU  - Baldini E
AD  - Medical Oncology Unit, San Luca Hospital, Lucca, Italy.
FAU - Cortellini, Alessio
AU  - Cortellini A
AD  - Operative Research Unit of Medical Oncology, Fondazione Policlinico Universitario 
      Campus Bio-Medico, Via Alvaro del Portillo 200, 00128, Roma, Italy; Department of 
      Surgery and Cancer, Hammersmith Hospital Campus, Imperial College London, London, 
      UK.
FAU - Brighenti, Matteo
AU  - Brighenti M
AD  - Medical Oncology, ASST Cremona, Cremona, Italy.
FAU - Santoni, Matteo
AU  - Santoni M
AD  - Oncology Unit, Macerata Hospital, Macerata, Italy.
FAU - Malorgio, Francesco
AU  - Malorgio F
AD  - Department of Oncology, Spirito Santo Hospital, Pescara, Italy.
FAU - Caminiti, Caterina
AU  - Caminiti C
AD  - Clinical & Epidemiological Research Unit, University Hospital of Parma, Parma, 
      Italy.
FAU - Tiseo, Marcello
AU  - Tiseo M
AD  - Medical Oncology Unit, University Hospital of Parma, Parma, Italy; Department of 
      Medicine and Surgery, University of Parma, Parma, Italy.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20240311
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 04Q9AIZ7NO (Pemetrexed)
RN  - DPT0O3T46P (pembrolizumab)
RN  - 49DFR088MY (Platinum)
RN  - 0 (B7-H1 Antigen)
RN  - 0 (Antibodies, Monoclonal, Humanized)
SB  - IM
MH  - Humans
MH  - Aged
MH  - *Lung Neoplasms/pathology
MH  - *Carcinoma, Non-Small-Cell Lung/pathology
MH  - Pemetrexed
MH  - Platinum/therapeutic use
MH  - B7-H1 Antigen
MH  - Prospective Studies
MH  - Retrospective Studies
MH  - Italy
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - *Antibodies, Monoclonal, Humanized
OTO - NOTNLM
OT  - Non-Small-Cell Lung Carcinoma
OT  - Pembrolizumab: Platinum chemotherapy
OT  - Pemetrexed
OT  - Real-world
COIS- Declaration of Competing Interest The authors declare the following financial 
      interests/personal relationships which may be considered as potential competing 
      interests: Lorenzo Belluomini received speakers' fee from Astra-Zeneca, MSD, 
      Roche, BMS, Amgen, Takeda. Emilio Bria has received grants or contracts from 
      Astra-Zeneca, Roche and honoraria for lectures from Merck-Sharp & Dome, 
      Astra-Zeneca, Pfizer, Eli-Lilly, Bristol-Myers Squibb, Novartis, Takeda and 
      Roche. Emilio Bria has been member of Data Safety Monitoring Board or Advisory 
      Board of Merck-Sharp & Dome, Pfizer, Novartis, Bristol-Myers Squibb, 
      Astra-Zeneca, and Roche. Fabrizio Citarella received speakers' fee from 
      Astra-Zeneca and Novartis. Fabrizio Citarella has received writing support fee 
      from BMS. Alessio Cortellini declares grants for consultancies/advisory boards 
      from MSD, OncoC4, IQVIA, AstraZeneca, Access Infinity, Ardelis Health, Alpha 
      Sight; speaker fees from Astra Zeneca, Eisai, Pierre-Fabre, MSD, 
      Sanofi/REGENERON; writing/editorial activity from BMS and MSD; travel support 
      from Sanofi and MSD. Alain Gelibter has been on advisory board for Astra-Zeneca, 
      MSD, Roche, BMS, Takeda. Alessandro Leonetti received speakers' fee from 
      Astra-Zeneca, MSD, Roche, Takeda and Sanofi. Alessandro Leonetti has been on 
      advisory board for BeiGene, Sanofi and Novartis. Alessandro Leonetti attended 
      editorial activities sponsored by Roche and Eli Lilly. Alessandro Leonetti 
      received travel support from MSD and Novartis. Francesca Mazzoni has been on 
      advisory board for Roche, MSD, BMS, Astra Zeneca, Takeda, Sanofi and Novartis. 
      Marcello Tiseo received speakers' and consultants' fee from Astra-Zeneca, Pfizer, 
      Eli-Lilly, BMS, Novartis, Roche, MSD, Boehringer Ingelheim, Otsuka, Takeda, 
      Pierre Fabre, Amgen, Merck, Sanofi. Marcello Tiseo received institutional 
      research grants from Astra-Zeneca and Boehringer Ingelheim. All remaining authors 
      have declared no conflicts of interest.
EDAT- 2024/03/16 05:42
MHDA- 2024/04/22 06:44
CRDT- 2024/03/15 19:01
PHST- 2024/02/29 00:00 [received]
PHST- 2024/03/03 00:00 [accepted]
PHST- 2024/04/22 06:44 [medline]
PHST- 2024/03/16 05:42 [pubmed]
PHST- 2024/03/15 19:01 [entrez]
AID - S0959-8049(24)00162-X [pii]
AID - 10.1016/j.ejca.2024.114006 [doi]
PST - ppublish
SO  - Eur J Cancer. 2024 May;202:114006. doi: 10.1016/j.ejca.2024.114006. Epub 2024 Mar 
      11.