Cisplatin, Etoposide, and Paclitaxel in the Treatment of Patients With Extensive Small-Cell Lung Carcinoma

1999 ◽  
Vol 17 (8) ◽  
pp. 2309-2309 ◽  
Author(s):  
Bonnie S. Glisson ◽  
Jonathan M. Kurie ◽  
Roman Perez-Soler ◽  
Nikolous J. Fox ◽  
William K. Murphy ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Small Cell Lung Carcinoma ◽  
Objective Response ◽  
Survival Rates ◽  
Maximum Tolerated Dose ◽  
Small Cell ◽  
Small Cell Lung ◽  
Cell Lung Carcinoma ◽  
Neutropenic Sepsis

PURPOSE: The combination of cisplatin, etoposide, and paclitaxel was studied in patients with extensive small-cell lung cancer in a phase I component followed by a phase II trial to determine the maximum-tolerated dose (MTD), characterize toxicity, and estimate response and median survival rates. PATIENTS AND METHODS: Forty-one patients were treated between October 1993 and April 1997. Doses for the initial cohort were cisplatin 75 mg/m2 on day 1, etoposide 80 mg/m2/d on days 1 to 3, and paclitaxel 130 mg/m2 on day 1 over 3 hours. Cycles were repeated every 3 weeks for up to six cycles. The MTD was reached in the first six patients. In these six patients and in the next 35 patients, who were entered onto the phase II trial, response and survival were estimated. RESULTS: At the initial dose level, one of six patients developed febrile neutropenia, and five of six achieved targeted neutropenia (nadir absolute granulocyte count, 100 to 1,000/μL) without any other dose-limiting toxicity, defining this level as the MTD. Grade 4 neutropenia was observed in 88 (47%) of 188 total courses administered at or less than the MTD. Neutropenia was associated with fever in only 17 (9%) of 188 courses, but two patients experienced neutropenic sepsis that was fatal. Nonhematologic toxicity greater than grade 2 was observed in 10 (5%) of 188 total courses, with fatigue, peripheral neuropathy, and nausea/vomiting most common. The overall objective response rate was 90% of 38 assessable patients: six complete responses (16%) and 28 partial responses(74%). Median progression-free and overall survival durations were 31 and 47 weeks, respectively. CONCLUSION: The combination of cisplatin, etoposide, and paclitaxel produced response and survival rates similar to those of other combinations and was well tolerated.

scholarly journals Phase II trial of a non‐platinum triplet for patients with advanced non‐small cell lung carcinoma (NSCLC) overexpressing ERCC1 messenger RNA

2019 ◽  
Vol 10 (3) ◽  
pp. 452-458 ◽  
Author(s):  
Shinnosuke Takemoto ◽  
Yoichi Nakamura ◽  
Hiroshi Gyoutoku ◽  
Hiroaki Senju ◽  
Daiki Ogawara ◽  
...  
Keyword(s):  
Phase Ii ◽  
Lung Carcinoma ◽  
Messenger Rna ◽  
Phase Ii Trial ◽  
Small Cell Lung Carcinoma ◽  
Small Cell ◽  
Small Cell Lung ◽  
Cell Lung Carcinoma

Results from a phase II study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in patients with PD-L1 unselected metastatic non-small cell lung carcinoma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9046-9046
Author(s):  
Timothy Dudley Clay ◽  
Margarita Majem ◽  
Enriqueta Felip ◽  
Bernard Doger ◽  
Enric Carcereny Costa ◽  
...  
Keyword(s):  
T Cell ◽  
Phase Ii ◽  
T Cell Activation ◽  
Lung Carcinoma ◽  
Advanced Nsclc ◽  
Small Cell Lung Carcinoma ◽  
Objective Response ◽  
Small Cell ◽  
Small Cell Lung ◽  
Cell Lung Carcinoma

9046 Background: Eftilagimod alpha (efti) is a soluble LAG-3 protein that binds to a subset of MHC class II molecules to mediate antigen presenting cell (APC) activation and CD8 T-cell activation. The stimulation of the dendritic cell network and subsequent T cell recruitment with efti may lead to stronger anti-tumor responses in combination than observed with pembrolizumab alone. We hereby report results of the 1st line non-small cell lung carcinoma (NSCLC) part of the phase II trial (NCT03625323). Methods: Patients (pts) with untreated, immunotherapy naïve, advanced NSCLC unselected for PD-L1 expression were recruited into part A. The study used a Simon's 2-stage design (17 pts planned for stage 1 and 19 pts for stage 2), with objective response rate (ORR) by iRECIST as the primary endpoint (EP). Secondary EPs include tolerability, disease control rate (DCR), progression free survival (PFS), overall survival (OS), PK, PD and immunogenicity. Efti is administered as 30 mg subcutaneous injection every 2 wks for 8 cycles and then every 3 wks for 9 cycles with pembrolizumab (200 mg intravenous infusion every 3 wks for up to 2 yrs). Imaging was performed every 8 weeks locally and with blinded independent central review (BICR) retrospectively. The study was approved by ethic committees and institutional review boards. Results: In total 36 pts were enrolled. At data cut-off (Jan 2021; median FU of 14 months), the median age was 69 yrs (range 53-84) and 69 % were male. The ECOG PS 0 and 1 was 42% and 58% respectively. Patients had squamous (42%) and non-squamous (58%) NSCLC and 95% presented with metastatic disease. All PD-L1 subgroups (TPS < 1 %, ≥ 1 % to ≤49 %; ≥50 %) were represented with 36% pts having ≥50% TPS. Pts received a median of 7.0 (range 1 – 31) pembrolizumab and 11.5 (range 1-22) efti administrations. Responses as per BICR and local read are shown in the table. ORR (local, iRECIST) by different PD-L1 subgroups was 27% for pts with TPS<1%, 39 % for TPS ≥1 %and 54% for ≥50 % TPS. Median PFS (n=36) was 8.2 months while median OS was not yet reached. The most common (> 20 %) treatment emergent adverse events (AEs) were asthenia (47 %), cough (36 %), decreased appetite (36 %), dyspnea (32 %), pruritus (31 %), fatigue (28 %), diarrhea (25 %), anemia (25 %), constipation (25 %) and back pain (22%). Two patients discontinued treatment due to adverse reactions (Grade 4 immune-mediated hepatitis, Grade 3 AST+ALT increase). Conclusions: Efti in combination with pembrolizumab is safe and shows encouraging antitumor activity in 1st line advanced NSCLC patients across all PD-L1 (TPS) levels. Clinical trial information: NCT03625323. [Table: see text]

scholarly journals A comparative study of immunotherapy as second-line treatment and beyond in patients with advanced non-small-cell lung carcinoma

2021 ◽  
pp. LMT47
Author(s):  
Jerónimo Rafael Rodríguez-Cid ◽  
Sonia Carrasco-Cara Chards ◽  
Iván Romarico González-Espinoza ◽  
Vanessa García-Montes ◽  
Julio César Garibay-Díaz ◽  
...  
Keyword(s):  
Lung Carcinoma ◽  
Small Cell Lung Carcinoma ◽  
Objective Response ◽  
Small Cell ◽  
Immune Checkpoints ◽  
Line Treatment ◽  
Second Line ◽  
Small Cell Lung ◽  
Total Study Population ◽  
Cell Lung Carcinoma

Background: Immunotherapy has demonstrated an improved overall survival (OS) and progression-free survival (PFS) as second-line treatment and subsequent lines compared with chemotherapy.  Materials and methods: This was a retrospective review among eight medical centers comprising 100 patients with a confirmed diagnosis of non-small-cell lung carcinoma, in their second-line treatment or beyond with immune checkpoints inhibitors treatment. The current study aimed to analyze effectiveness of immunotherapy in second-line treatment or further in the Mexican population, using PFS rate, OS rate and the best objective response to treatment by RECIST 1.1 as a surrogate of effectiveness. Results: In total, 100 patients met the criteria for enrollment in the current study. From the total study population, 49 patients (49.0%) were male and 51 (51.0%) were female, with an average age of 60 years and stage IV as the most prevalent clinical stage at the beginning of the study. A total of 61 patients (61.0%) had partial response; 11 (11.0%) stable disease; 2 (2.0%), complete response, 4 (4.0%), progression; and 22 (22.0%) were nonevaluable. We found a median PFS of 4 months (95% CI: 3.2–4.7 months) and an OS of 9 months (95% CI: 7.2–10.7 months). Conclusion: The response to immunotherapy is similar, with an improvement in OS and PFS, independent of which drug is used. Patients using nivolumab had a better survival, although that was not statistically significant.

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