scholarly journals Single-institute comparison of the efficacy of systemic chemotherapy for oesophagogastric junction adenocarcinoma and stomach adenocarscinoma in a metastatic setting

ESMO Open ◽  
2020 ◽  
Vol 5 (2) ◽  
pp. e000595 ◽  
Author(s):  
Izuma Nakayama ◽  
Daisuke Takahari ◽  
Takeru Wakatsuki ◽  
Hiroki Osumi ◽  
Keisho Chin ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Anatomical Location ◽  
Limited Information ◽  
Diffuse Type ◽  
Borrmann Type ◽  
Oesophagogastric Junction ◽  
Metastatic Setting ◽  
Significant Difference ◽  
Doublet Chemotherapy ◽  
Platinum Doublet

BackgroundDifferent approaches are used to treat resectable tumours in patients having adenocarcinoma at the oesophagogastrointestinal junction (EGJ) or in the stomach. However, there is limited information about treatment efficacy for patients at metastatic stage. A recent molecular analysis of upper gastrointestinal tract adenocarcinoma revealed that the anatomical location can influence the molecular backgrounds of tumours. This study sought to elucidate whether different therapeutic approaches should be used for EGJ tumours relative to those in the stomach.MethodsThis retrospective cohort study was conducted at a single institute in Japan. Patients having metastatic or recurrent adenocarcinoma in the EGJ or stomach who underwent platinum doublet chemotherapy between January 2007 and August 2014 were enrolled. Patients in the EGJ tumour group had tumours having an epicentre within 2 cm proximal or 5 cm distal to the estimated anatomical EGJ and cardia.ResultsAmong 378 consecutively enrolled patients, 61 were grouped into the EGJ group and the remainder comprised the stomach group. The EGJ group had more men and lower incidence of diffuse type and Borrmann type IV tumours and peritoneum metastasis compared with the stomach group. The median overall survival of patients in the EGJ and stomach groups was similar (17.3 months (95% CI 13.5 to 23.2) vs 14.5 months (95% CI 13.3 to 16.4)). No statistically significant difference was observed in progression-free survival. Although the overall postprogression survival differed significantly between the EGJ and stomach groups (8.2 months (95% CI 5.7 to 12.7) vs 7.1 months (95% CI 6.1 to 7.8)), on grouping patients by histological type, the two groups exhibited similar postprogression survival. Multivariate analysis demonstrated that diffuse-type histology, higher serum CA19-9 levels and neutrophil to lymphocyte ratios were independent poor prognostic factors.ConclusionsDifferent clinicopathological features of EGJ adenocarcinoma were not associated with clinical outcomes of platinum doublet chemotherapy. Histological subtype rather than anatomical location has more significance for treatment decisions for advanced gastric cancers.

scholarly journals Evaluation of efficacy and toxicity of nivolumab combined with or without docetaxel in patients with advanced NSCLC

2021 ◽  
Author(s):  
Yang Wang ◽  
Jun Nie ◽  
Ling Dai ◽  
Weiheng Hu ◽  
Jie Zhang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Advanced Nsclc ◽  
Objective Response ◽  
Progression Free Survival ◽  
Meaningful Improvement ◽  
Free Survival ◽  
Significant Difference ◽  
Grade 3 ◽  
Doublet Chemotherapy ◽  
Platinum Doublet

Abstract Background The combination of PD-1/PD-L1 inhibitor and chemotherapy has been clinically confirmed to be beneficial as the first-line treatment of patients with advanced NSCLC. This study aimed to assess the effect of nivolumab + docetaxel versus nivolumab monotherapy in patients with NSCLC after the failure of platinum doublet chemotherapy. Materials and methods The efficacy and toxicity of nivolumab + docetaxel combination therapy versus nivolumab monotherapy were compared in this retrospective study. Primary endpoint of the study was progression-free survival (PFS), and the secondary endpoints were objective response rate (ORR), overall survival (OS), and toxicity. Results Between November 2017 and December 2019, 77 patients were included in this study, with 58 patients in the nivolumab group and 19 in the nivolumab + docetaxel group. The median follow-up was 18 months, and the PFS was 8 months for patients receiving nivolumab + docetaxel and 2 months for those receiving nivolumab alone (p = 0.001), respectively. Nivolumab + docetaxel showed superior OS compared with nivolumab, with the median OS unreached versus 7 months (p = 0.011). Among patients without EGFR/ALK variation, compared to nivolumab monotherapy, nivolumab + docetaxel showed better PFS (p = 0.04) and OS (p  = 0.05). There was no significant difference in grade 3–4 adverse events (AEs) between the two groups (p = 0.253). Conclusions The combination of nivolumab and docetaxel demonstrated a meaningful improvement in progression-free survival and overall survival compared to nivolumab monotherapy, in patients with NSCLC after the failure of platinum doublet chemotherapy, irrespective of EGFR/ALK variation status.

A phase 2, open-label, multicenter study to evaluate the efficacy, safety, and tolerability of KN046 in combination with chemotherapy in subjects with advanced non-small cell lung cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9060-9060
Author(s):  
Yunpeng Yang ◽  
Wenfeng Fang ◽  
Yan Huang ◽  
Xingya Li ◽  
Siyuan Huang ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Objective Response ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Efficacy Evaluation ◽  
Open Label ◽  
Pivotal Phase ◽  
Doublet Chemotherapy ◽  
Platinum Doublet

9060 Background: Dual blockade of PD-1 and CTLA-4 has shown improved overall survival (OS) in combination with a short course of chemotherapy. KN046 is a novel bispecific antibody that blocks both PD-L1 interaction with PD-1/CD80 and CTLA-4 interaction with CD80/CD86. We hypothesized that KN046 could be combined with a full course of chemotherapy and build more durable clinical benefit. Methods: This study enrolled systemic treatment naive, stage IV NSCLC patients (pts). Eligible pts received KN046 plus platinum doublet chemotherapy until progressive disease, unacceptable toxicity, withdrawal of informed consent or death. Efficacy evaluation was performed by investigators per RECIST 1.1. Safety and tolerability were assessed per NCI-CTCAE v5.0. Results: As of the Jan. 19, 2021, 87 pts [Cohort 1 (n = 51), Cohort 2 (n = 36)] have been enrolled with 83 pts having tumor PD-L1 expression data (PD-L1 ≥1%: 55.4%; PD-L1 < 1%: 44.6%). 33.3% pts remained on the study treatment and 66.7% pts discontinued treatment due to disease progression (27.6%), TEAE (13.8%), death (9.2%) and other reasons (16%). The median treatment duration of KN046 was 21 weeks (range: 1.6̃68.7 weeks). Treatment related TEAE (TRAE) occurred in 92% pts. 25.3% pts experienced Grade≥3 TRAE [diarrhoea (5.7%), alanine aminotransferase increased (4.6%), infusion related reaction (3.4%), rash (3.4%), aspartate aminotransferase increased, dermatitis allergic and immune-mediated pneumonitis (2.3%, respectively), anaphylactoid reaction, autoimmune hepatitis, back pain, bilirubin conjugated increased, hypertension, neutrophil count decreased, platelet count decreased, pneumonitis, rash maculo-papular, septic shock and white blood cell count decreased (1.1%, respectively). In 81 efficacy evaluable pts, the overall objective response rate (ORR) was 50.6% (95% CI: 39.3%,61.9%) and disease control rate (DCR) was 87.7% (95% CI: 78.5%-93.9%). The ORR and DCR in pts with non-squamous NSCLC (n = 48) were 45.8% (95% CI: 31.4%, 60.8%) and 89.6% (95% CI: 77.3%, 96.5%). The ORR and DCR in pts with squamous NSCLC (n = 33) were 57.6% (95% CI: 39.2%, 74.5%) and 84.8% (95% CI: 68.1%, 94.9). Progression free survival (PFS) and OS events have occurred in 53% and 18% patients. Median PFS was 5.9 (95%CI: 5.3, 8.7) months. Median OS was not reached. OS rate at 12 and 15 months were both 74.9%. Similar OS curves have been observed in PD-L1 ≥1% and PD-L1 < 1% pts. In PD-L1 ≥1% patients, median PFS was 6.7 months (10.8 months for PD-L1 ≥1% squamous NSCLC pts). Conclusions: KN046 combined with platinum doublet chemotherapy is tolerated and has shown promising clinical benefit as IL treatment for stage IV NSCLC particularly in PD-L1≥1% tumors and squamous histology. Pivotal Phase III trial in advanced unresectable or metastatic squamous NSCLC is currently ongoing. Clinical trial information: NCT04054531.

Incidence and patterns of immune related adverse events (irAEs) during chemoimmunotherapy (ChemoIO) in patients with advanced nonsquamous NSCLC.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e20705-e20705
Author(s):  
Pradnya Dinkar Patil ◽  
Alexia Zagouras ◽  
Wei (Auston) Wei ◽  
Nathan A. Pennell
Keyword(s):  
Descriptive Statistics ◽  
Intensive Chemotherapy ◽  
Significant Morbidity ◽  
Organ Systems ◽  
Significant Difference ◽  
History Of ◽  
Former Smokers ◽  
Nonsquamous Nsclc ◽  
Doublet Chemotherapy ◽  
Platinum Doublet

e20705 Background: Based on superior outcomes noted in KEYNOTE-189 with the addition of pembrolizumab to platinum doublet chemotherapy, a majority of pts with nonsquamous NSCLC are now treated with chemoIO. irAEs can cause significant morbidity and occasionally mortality in pts treated with immunotherapy. Since chemotherapy is immunosuppressive, it is plausible that incidence of irAEs would be lower in pts receiving chemoIO compared to immunotherapy. The incidence of irAEs in KEYNOTE-189 was 22.7% vs 29.2% in KEYNOTE-024 with pembrolizumab monotherapy. We sought to evaluate the incidence and patterns of irAEs in pts with advanced nonsquamous NSCLC treated with chemoIO at our institution and to determine if the rate varied with the intensity of chemotherapy [carboplatin/ pemetrexed/ pembrolizumab (CPP) vs pemetrexed/ pembrolizumab (PP)]. Methods: We retrospectively reviewed the charts of 73 pts with advanced nonsquamous NSCLC who received CPP followed by maintenance PP. In addition to clinicopathologic variables, we noted the date, incidence, type and grade of irAEs. Descriptive statistics were used to report the incidence and patterns of irAEs. McNemar’s test was used to determine if there was a significant difference in rate of irAEs during CPP vs PP. Results: Of the 73 pts, 52% were females, 67% former smokers, 49% had previously received radiation and 11% had a history of autoimmune disease. 35 pts received 4 cycles of CPP. 21 patients (28%) developed irAEs, of which 6 had irAEs during CPP and 15 developed irAEs on PP. The rate of irAEs was significantly higher after stopping carboplatin (p = 0.049). 10 pts (13%) stopped pembrolizumab due to irAEs. Organ systems involved and grade of irAEs are listed below. Conclusions: The immunosuppressive effects of intensive chemotherapy may be protective against irAEs in pts receiving chemoIO. [Table: see text]

Randomized Phase III Trial of Platinum-Doublet Chemotherapy Followed by Gefitinib Compared With Continued Platinum-Doublet Chemotherapy in Japanese Patients With Advanced Non–Small-Cell Lung Cancer: Results of a West Japan Thoracic Oncology Group Trial (WJTOG0203)

2010 ◽  
Vol 28 (5) ◽  
pp. 753-760 ◽  
Author(s):  
Koji Takeda ◽  
Toyoaki Hida ◽  
Tosiya Sato ◽  
Masahiko Ando ◽  
Takashi Seto ◽  
...  
Keyword(s):  
Overall Survival ◽  
Progression Free Survival ◽  
Sequential Therapy ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Phase Iii Trial ◽  
Free Survival ◽  
Doublet Chemotherapy ◽  
Platinum Doublet

Purpose Gefitinib is a small molecule inhibitor of the epidermal growth factor receptor tyrosine kinase. We conducted a phase III trial to evaluate whether gefitinib improves survival as sequential therapy after platinum-doublet chemotherapy in patients with advanced non–small-cell lung cancer (NSCLC). Patients and Methods Chemotherapy-naïve patients with advanced stage (IIIB/IV) NSCLC, Eastern Cooperative Oncology Group performance status of 0 to 1, and adequate organ function were randomly assigned to either platinum-doublet chemotherapy up to six cycles (arm A) or platinum-doublet chemotherapy for three cycles followed by gefitinib 250 mg orally once daily, until disease progression (arm B). Patients were stratified by disease stage, sex, histology, and chemotherapy regimens. The primary end point was overall survival; secondary end points included progression-free survival, tumor response, safety, and quality of life. Results Between March 2003 and May 2005, 604 patients were randomly assigned. There was a statistically significant improvement in progression-free survival in arm B (hazard ratio [HR], 0.68; 95% CI, 0.57 to 0.80; P < .001); however, overall survival results did not reach statistical significance (HR, 0.86; 95% CI, 0.72 to 1.03; P = .11). In an exploratory subset analysis of overall survival by histologic group, patients in arm B with adenocarcinoma did significantly better than patients in arm A with adenocarcinoma (n = 467; HR, 0.79; 95% CI, 0.65 to 0.98; P = .03). Conclusion This trial failed to meet the primary end point of OS in patients with NSCLC. The exploratory subset analyses demonstrate a possible survival prolongation for sequential therapy of gefitinib, especially for patients with adenocarcinoma.

Collective analysis of efficacy and safety of patients with advanced hepatocellular carcinoma (HCC) enrolled into early-phase clinical trials.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 320-320
Author(s):  
Vinu Madhusudanannair ◽  
Brad H. Pollock ◽  
Norma Ketchum ◽  
Steven Weitman ◽  
John Sarantopoulos ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Early Phase ◽  
Progression Free Survival ◽  
Cytotoxic Agents ◽  
Rank Test ◽  
Advanced Hepatocellular Carcinoma ◽  
Limited Information ◽  
Efficacy And Safety ◽  
Advanced Hcc ◽  
Significant Difference

320 Background: Sorafenib is the only approved systemic therapy in HCC. Clinical trials in HCC often exclude patients with Child-Pugh Stage (CPS) B/C cirrhosis. Furthermore, limited information on outcomes specific to HCC population are reported from early clinical trials. We evaluated the efficacy and safety of early phase clinical trial agents used to treat HCC. Methods: 42 consecutive patients with advanced HCC enrolled in one of the 53 phase I trials at our institution between 2003- 2013 were analyzed. Median progression free survival (mPFS) and overall survival (mOS) were estimated from Kaplan-Meier curves along with medians and groups were compared with the log rank test. The magnitude of association and survival was estimated with the hazard ratio (HR). Results: Median age 63 (33–84), males 75 %, ECOG PS 0–1 92%, CPS A 19%, B 71.7% and C 9.4%. 41.5% subjects were treated with prior Sorafenib. Class of agents used included cytotoxics such as microtubule inhibitors (26.4%), anti-folates (5.7%), alkylators (1.9%), topoisomerase inhibitors (5.7%), and non-cytotoxic agents such as pro-apoptotic therapies (15.1%), anti-VEGF (17%) mTOR/ EGFR/ IGFR (22.6%), and HDAC inhibitors (5.7%). When evaluating for efficacy for all patients, the mPFS (95% CI) =2.3 (1.9, 3.9) months and 12 month OS ± SEM = 59% ± 15%. The mPFS was 3.7 months versus 2.1 months for CPS A subjects and CPS B/C subjects respectively (HR 1.5, CI: 0.7- 3.5, p= 0.31). The 12-month OS was 80 ± 18% among pts with CPS A vs 74 ± 8% in CPS B. Grade 3-4 toxicity included hematologic (13.2%) and hepatic (20.8%), with no significant difference in toxicity between the two CPS groups. Finally, cytotoxic agents had a mPFS of 3.1 months (95% CI: 2.1- 4.4) vs 1.9 months (95% CI: 1.1- 2.3) for non-cytotoxic therapy (HR 1.56, 95% CI: 0.8–3.07, p = 0.19). The 12 month OS was 46% vs 50% between these two groups (HR 6.2, CI: 1.3–29.3, p = 0.009). Conclusions: Patients with advanced HCC have a modest survival that is compounded further by poor liver function. Our data suggests that there are no significant differences in efficacy and safety between HCC patients with varying liver dysfunction based on CPS status.

Comparison of fluoropyrimidine based (FP)and taxane based platinum doublets (TP) in frontline treatment of patients with metastatic gastroesophageal adenocarcinomas (mGEAC): A retrospective analysis.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15604-e15604
Author(s):  
Hibah Ismail ◽  
AMR Mohamed ◽  
Yeohan Song ◽  
Nadine Abdallah ◽  
Malini Surapaneni ◽  
...  
Keyword(s):  
Response Rate ◽  
Objective Response ◽  
Progression Free Survival ◽  
Rank Test ◽  
Continuous Variables ◽  
Weighted Estimates ◽  
Significant Difference ◽  
Key Factor ◽  
Frontline Treatment ◽  
Platinum Doublet

e15604 Background: Although, fluoropyrimidine (FP) and taxane based platinum doublet (TP) chemotherapy have demonstrated efficacy against advanced gastroesophageal cancer, these two regimens have not been compared in prospective trials. We retrospectively compared fluoropyrimidine based (FP)and taxane based platinum doublet (TP)chemotherapy in the frontline setting in patients with mGEAC. Methods: Patients with mGEAC treated at Karmanos Cancer Institute between 2000-2014 were reviewed. We compared progression free survival (PFS), Response rate (RR), and toxicity profile of the two regimens. Outcomes were analyzed using weighted estimates. Fisher’s exact tests and Kruskal-Wallis tests were used for categorical and continuous variables, respectively. Survival differences were assessed by a log-rank test. Results: Of the total136 patients, 39% (53) received FP and 61% (83) received TP chemotherapy. Males were 68% (94) of the patients. Gastric, esophageal and gastroesophageal adenocarcinomas contributed to 47% (64), 26.5% (36) and 26.5% (36) of the cases respectively. FOLFOX was the main regimen in FP (62%), followed by 5FU cisplatin (38%). Carboplatin paclitaxel was the main regimen in the TP group. There was no statistically significant difference between the FP and TP arms in terms of PFS, RR, and median OS. The estimated median PFS was 6.39 (95% CI, 5.54-11.15) for the FP group vs 6.92 months (95% CI, 6.13-9.02) for the TP group, (p = 0.90). Objective response rate was (48% for FP group Vs 56% for TP group, p = 0.70). There was more significant grade 4-5 toxicity in FP vs TP based regimen (79 % vs 55 % respectively, p = 0.004). Conclusions: The efficacy of fluoropyrimidine platinum doublet chemotherapy appears to be as comparable to taxane based platinum doublet in the frontline treatment of mGEC. However, the fluorpyrimidine based regimen appears to have more toxicity. Consideration of treatment adverse effects ought to be a key factor in determining the choice of either regimen in mGEAC.

scholarly journals A survival analysis of surgically treated incidental low-grade glioma patients

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lingcheng Zeng ◽  
Qi Mei ◽  
Hua Li ◽  
Changshu Ke ◽  
Jiasheng Yu ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Low Grade Glioma ◽  
Low Grade ◽  
Total Resection ◽  
Surgical Timing ◽  
Asymptomatic Group ◽  
Free Survival ◽  
Symptomatic Group ◽  
Significant Difference ◽  
Asymptomatic Phase

AbstractTo evaluate the surgical effect on survival in patients with incidental low-grade glioma (LGG) through comparison between asymptomatic and symptomatic patients. The medical records of surgically treated adult cerebral incidental LGG (iLGG) patients in our department between January 2008 and December 2015 were retrospectively reviewed. The survival of patients was calculated starting from the initial imaging diagnosis. Factors related to progression-free survival (PFS), overall survival (OS) and malignant progression-free survival (MPFS) were statistically analyzed. Seventy-five iLGG patients underwent surgery: 49 in the asymptomatic group, who underwent surgery in the asymptomatic period, and 26 in the symptomatic group, who underwent surgery after the tumor had grown and the patients had developed tumor-related symptoms. Significantly more tumors were initially located adjacent to the functional area in the symptomatic group than in the asymptomatic group (P < 0.05), but there was no significant difference in the total resection rate between the two groups. The incidence of postoperative complications (15.4%) and postoperative epilepsy (23.1%) was higher in the symptomatic group than in the asymptomatic group (4.1% and 10.2%, respectively). Multivariate analysis showed that surgical timing, namely, surgery performed before or after symptom occurrence, had no significant effect on PFS, OS or MPFS, while total resection significantly prolonged PFS, OS and MPFS, and the pathology of oligodendroglioma was positively correlated with PFS and OS (P < 0.05). Surgical timing for iLGGs should facilitate total resection. If total resection can be achieved, even after symptom occurrence, patients can achieve comparable survival benefits to those treated with surgery in the asymptomatic phase.

scholarly journals Efficacy of lenvatinib for unresectable hepatocellular carcinoma based on background liver disease etiology: multi-center retrospective study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Atsushi Hiraoka ◽  
Takashi Kumada ◽  
Toshifumi Tada ◽  
Joji Tani ◽  
Kazuya Kariyama ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Prognostic Factors ◽  
Liver Disease ◽  
Hazard Analysis ◽  
Progression Free Survival ◽  
Significant Prognostic Factor ◽  
Disease Etiology ◽  
Alcoholic Fatty Liver ◽  
Free Survival ◽  
Significant Difference

AbstractIt was recently reported that hepatocellular carcinoma (HCC) patients with non-alcoholic steatohepatitis (NASH) are not responsive to immune-checkpoint inhibitor (ICI) treatment. The present study aimed to evaluate the therapeutic efficacy of lenvatinib in patients with non-alcoholic fatty liver disease (NAFLD)/NASH-related unresectable-HCC (u-HCC). Five hundred thirty u-HCC patients with Child–Pugh A were enrolled, and divided into the NAFLD/NASH (n = 103) and Viral/Alcohol (n = 427) groups. Clinical features were compared in a retrospective manner. Progression-free survival (PFS) was better in the NAFLD/NASH than the Viral/Alcohol group (median 9.3 vs. 7.5 months, P = 0.012), while there was no significant difference in overall survival (OS) (20.5 vs. 16.9 months, P = 0.057). In Cox-hazard analysis of prognostic factors for PFS, elevated ALT (≥ 30 U/L) (HR 1.247, P = 0.029), modified ALBI grade 2b (HR 1.236, P = 0.047), elevated AFP (≥ 400 ng/mL) (HR 1.294, P = 0.014), and NAFLD/NASH etiology (HR 0.763, P = 0.036) were significant prognostic factors. NAFLD/NASH etiology was not a significant prognostic factor in Cox-hazard analysis for OS (HR0.758, P = 0.092), whereas AFP (≥ 400 ng/mL) (HR 1.402, P = 0.009), BCLC C stage (HR 1.297, P = 0.035), later line use (HR 0.737, P = 0.014), and modified ALBI grade 2b (HR 1.875, P < 0.001) were significant. Lenvatinib can improve the prognosis of patients affected by u-HCC irrespective of HCC etiology or its line of treatment.

scholarly journals A phase II study of cisplatin plus vinorelbine combined with atezolizumab as adjuvant therapy for completely resected non-small-cell lung cancer with EGFR mutation (West Japan Oncology Group 11719L/ADJUST study)

2021 ◽  
Vol 13 ◽  
pp. 175883592098764
Author(s):  
Ryota Shibaki ◽  
Hiroaki Akamatsu ◽  
Terufumi Kato ◽  
Kazumi Nishino ◽  
Morihito Okada ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adjuvant Therapy ◽  
Egfr Mutation ◽  
Phase Ii Study ◽  
Small Cell ◽  
Small Cell Lung ◽  
Resected Nsclc ◽  
Egfr Mutated ◽  
Doublet Chemotherapy ◽  
Platinum Doublet

Background: Epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) is a standard treatment in EGFR-mutated advanced non-small-cell lung cancer (NSCLC); however, previous data have suggested that EGFR-TKI has limited potential as adjuvant therapy. On the contrary, based on subset analysis with the immune checkpoint inhibitor (ICI) plus platinum-doublet chemotherapy in advanced NSCLC with EGFR mutation, we hypothesized that this combination was worth testing as adjuvant therapy in patients with EGFR-mutated NSCLC. Methods: Herein, we introduce our phase II study of cisplatin plus vinorelbine combined with atezolizumab as adjuvant therapy for completely resected NSCLC with EGFR mutation. Accrued patients will be pathological stage II–IIIA with completely resected NSCLC and whose tumors have EGFR mutation. Treatment comprises four cycles of cisplatin plus vinorelbine combined with atezolizumab followed by maintenance with atezolizumab. The primary endpoint is the disease-free survival (DFS) rate at 2 years. Secondary endpoints are DFS, overall survival, and safety. In total, 18 patients will be enrolled in this study. Discussion: Ongoing phase III trials of adjuvant ICI allow the inclusion of patients with EGFR mutation, but our current trial will provide the earliest clinical data on the efficacy of platinum-doublet chemotherapy with atezolizumab.

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