1349P - A prospective study on clinicians’ attitudes and survival outcomes for patients with NSCLC and poor performance status in the immunotherapy era: PICASO study (GOIRC-04-2020)

Background

Up to 30% of patients (pts) with advanced NSCLC have ECOG performance status (PS) 2 at diagnosis. They are often excluded from clinical trials, including those with immunotherapy, limiting the evidence on systemic treatments.

Methods

We led a prospective, observational study in 20 Italian centers focused on pts with advanced NSCLC and ECOG PS 2. Pts with EGFR mutations, ALK fusions or receiving first-line targeted treatments were excluded. We recorded physicians’ attitudes in addressing first-line treatments and clinical outcomes. The primary endpoint was progression-free rate at 6 months (6-mos PFR).

Results

199 consecutive pts were included from March 2022 to October 2023. Among the 196 pts with complete information at data lock (April 30^th, 2024), median age was 73 years (range 43-91), with 60% males. PS was attributed to tumor burden in 175 pts (89%). 42 pts (21%) were candidate to best supportive care (BSC), 48 (24%) to mono-chemo, 14 (7%) to doublet-chemo, 40 (20%, all with PD-L1 >= 50%) to anti-PD-1/PD-L1 monotherapy (IO-mono), 52 (27%) to chemo-immunotherapy combinations (chemo-IO). 80% of pts with PD-L1 >= 50% received IO-mono, and 41% of pts with PD-L1 < 50% received chemo-IO. At a median follow-up of 8.9 months, 6-mos PFR was 15.9%, with median PFS 1.6 months (95%CI 1.3 – 1.9). For 154 pts receiving active treatment, 6-mos PFS was 18.2%, with median PFS 1.9 months (95%CI 1.6-2.2). 6-mos PFR was 7.3% for BSC, 8.3% for mono-chemo, 0% for doublet-chemo, 29.6% for IO-mono, 22.9% for chemo-IO. Overall survival rate at 6 months (6-months OSR) was 28.9%, with median OS 2.8 months (95% CI 2.1-3.6). For pts receiving active treatment, 6-months OSR was 32.8% and median OS 3.5 months (95%CI 2.5-4.5). 6-mos OSR was 14.2% for BSC, 25.7% for mono-chemo, 30.1% for doublet-chemo, 41.8% for IO-mono, 33% for chemo-IO. Median OS was 4.3 months (95% CI 1.7-6.9) for IO-mono and 3.7 months (95% CI 2.8-4.6) for chemo-IO. Safety data will be presented at the meeting.

Conclusions

Less than half of pts with NSCLC and ECOG PS 2 were candidates to the regimens recommended for fit pts (i.e. IO-mono or chemo-IO according to PD-L1 expression). Even with immunotherapy, most of these pts have a poor outcome.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Gruppo Oncologico di Ricerca Clinica (GOIRC), Parma, Italy.

Funding

Gruppo Oncologico di Ricerca Clinica (GOIRC), Parma, Italy.

Disclosure

C. Bennati: Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Board: BMS, AstraZeneca. F. Mazzoni: Financial Interests, Personal, Advisory Board: MSD, AstraZeneca, Roche, Takeda, Sanofi, Novartis, BMS. S. Pilotto: Financial Interests, Personal, Invited Speaker: Bristol Myers Squibb, AstraZeneca, MSD, Roche, Amgen, Novartis, Takeda, Sanofi; Financial Interests, Personal, Advisory Board: MSD, Amgen, AstraZeneca, Novartis, Eli Lilly, Sanofi; Financial Interests, Research Grant: Bristol Myers Squibb, AstraZeneca; Non-Financial Interests, Principal Investigator: AstraZeneca, Roche, BMS. E. Bria: Financial Interests, Personal, Advisory Board: AZ, Roche, BMS, MSD, Eli Lilly, Pfizer, Novartis, Takeda; Financial Interests, Personal, Invited Speaker: AZ, Roche, BMS, MSD, Eli Lilly, Pfizer, Novartis, Takeda; Financial Interests, Institutional, Research Grant: AZ, Roche. F. Passiglia: Financial Interests, Personal, Advisory Board: AstraZeneca, Janssen, Amgen, Sanofi, BMS, MSD, Roche, BeiGene, Novartis, Thermo Fisher Scientific. S. Novello: Financial Interests, Personal, Invited Speaker: AZ, MSD, Eli Lilly, Novartis, BeiGene, Amgen, Thermo Fisher; Financial Interests, Personal, Advisory Board: BI, BMS, Pfizer, Takeda, Roche, Sanofi, Amgen, J&J; Financial Interests, Institutional, Coordinating PI, IIT: MSD, BI; Financial Interests, Institutional, Coordinating PI: AZ, AMG, Eli Lilly, Sanofi, J&J, Roche; Non-Financial Interests, Leadership Role, president of this European advocacy: WALCE; Non-Financial Interests, Member: IASLC, AIOM, ASCO. M. Di Maio: Financial Interests, Personal, Advisory Board, Consultancy about clinical trial methodology and clinical trial results interpretation: Novartis; Financial Interests, Personal, Advisory Board, Consultancy about immunotherapy in SCLC: Roche; Financial Interests, Personal, Advisory Board, Consultancy about role and interpretation of patient-reported outcomes and quality of life in clinical trials: Takeda; Financial Interests, Personal, Advisory Board, Advisory board about the role of chemotherapy and hormonal treatment in hormone-sensitive prostate cancer: Janssen; Financial Interests, Personal, Advisory Board, Consultancy about the results obtained with lorlatinib and dacomitinib in advanced non-small cell lung cancer: Pfizer; Financial Interests, Personal, Advisory Board, Consultancy about role of osimertinib as adjuvant treatment of NSCLC: AstraZeneca; Financial Interests, Personal, Advisory Board, Participation in advisory boards about olaparib in pancreatic cancer, about olaparib in prostate cancer, and about immunotherapy in lung cancer: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board, Consultant for the new indication of avelumab in urothelial cancer: Merck Serono; Financial Interests, Personal, Advisory Board, Advisory board about treatment of gastric cancer: Amgen; Financial Interests, Personal, Advisory Board, Lesson for the personnel of the drug company about quality of life, patient-reported outcomes and methodological aspects of clinical trials: GSK; Financial Interests, Personal, Advisory Board, Advisory board about trastuzumab deruxtecan in gastric cancer: Daiichi Sankio; Financial Interests, Personal, Advisory Board, Advisory board about Moovcare and remote monitoring of symptoms in patients with cancer: Viatris; Financial Interests, Institutional, Research Grant, Financial support and drug supply for the Meet-URO12 trial (niraparib as maintenance treatment of urothelial carcinoma after first-line treatment with platinum-based chemotherapy): Tesaro - GSK; Financial Interests, Institutional, Local PI, Local PI of trial with tislelizumab in hepatocellular carcinoma: BeiGene; Financial Interests, Institutional, Local PI, Local PI of a trial with cabozantinib and atezolizumab in advanced HCC: Exelixis; Financial Interests, Institutional, Local PI, Local PI of a trial with atezolizumab and bevacizumab in advanced HCC: Roche; Financial Interests, Institutional, Local PI, Local PI of trials with pembrolizumab in hepatocellular carcinoma: Merck Sharp & Dohme; Financial Interests, Institutional, Local PI, Local PI of a trial with sasanlimab in NMI bladder cancer: Pfizer. M. Tiseo: Financial Interests, Personal, Advisory Board: AstraZeneca, Boehringer Ingelheim, Roche, Amgen, Takeda, MSD, Merck, BMS, Pfizer, Eli Lilly, Novartis, Janssen, Daiichi Sankyo; Financial Interests, Institutional, Research Grant: AstraZeneca, Boehringer Ingelheim, Roche. All other authors have declared no conflicts of interest.