Background: Advanced GC pts have limited treatment options and poor prognosis. Immune checkpoint inhibitors (ICIs) showed promising activities in pretreated pts, especially for those with high PD-L1 expression. Blockade of TGF-b pathway may enhance the tumor response to ICIs.Methods: This phase I study composed of a dose escalation and expansion (ESC & EXP) period in solid tumors and multiple clinical expansion cohorts. Based on findings of the ESC & EXP period, 30 mg/kg Q3W was determined as RP2D. In the GC clinical expansion cohort, pts who had progressed on or were intolerant to 2L standard therapies were given SHR-1701 at the RP2D. Prior ICIs were not allowed. Primary endpoint was ORR per RECIST v1.1.Results: 35 pts were enrolled: stage IV, 91.4%; 2L prior systemic therapies, 54.3%. By Apr 6, 2021, median SHR-1701 exposure was 12.0 wk (range 3.0-64.9). Of the 31 pts with post-baseline scan(s), 16 (51.6%) pts showed tumor shrinkage. 1 CR and 7 PR were achieved, and ORR was 25.8% (95% CI 11.9-44.6). 2 PR were not confirmed yet as there was no consequent scan after first PR as of data cutoff. Confirmed ORR was 19.4% (95% CI 7.5-37.5; 1 CR + 5 PR; ongoing responses: 66.7% [4/6]). DCR was 41.9% (95% CI 24.5-60.9). CBR (CR + PR + SD23 wk) was 25.8% (95% CI 11.9-44.6). Median PFS was 1.4 mo (95% CI 1.3-9.6), and 6-mo PFS rate was 38.7% (95% CI 22.0-55.1). Median OS was not reached yet. Exploratory analyses showed a trend towards favourable responses for pts with a PD-L1 CPS 5 (Table ). Most common TRAEs (incidence >10% in 35 pts) were rash, increased AST/ALT, decreased FT3 and pruritus. Incidence of irAEs was 45.7%. Grade 3 or 4 TRAEs occurred in 17.1% of pts, and no pts died due to TRAEs. Incidence of grade 3 irAEs was 11.4%. Table: 1375P Efficacy outcomes* in all patients and subgroups by PD-L1 expression All patients (N[31) CPS <5 (N[10) CPS ‡5 (N[9) ORR, n (%; 95% CI) 6 (19.4%; 7.
IntroductionRapid on‐site evaluation (ROSE) has the potential to increase endobronchial ultrasound transbronchial lung biopsy with guide sheath (EBUS‐GS‐TBLB) accuracy in the diagnosis of peripheral lung cancer. However, studies have reported controversial results.ObjectivesThe aim of the study was to evaluate the diagnosis value of EBUS‐GS‐TBLB combination with ROSE in peripheral lung cancer.MethodsA total of 138 patients undergoing EBUS‐GS‐TBLB and ultimately diagnosed with lung cancer were allocated into the ROSE group and non‐ROSE group. The result of the diagnostic yields, number of biopsy sites, the complication, cytopathological diagnostic cost and procedure times of EBUS‐GS‐TBLB with ROSE and without ROSE were compared.ResultsThe diagnostic yields of TBLB were 87.8% and 78.1% in ROSE group and non‐ROSE group, respectively (P < .05). The number of biopsy, procedure times and the percentage of the complication in ROSE group was significantly lower than in non‐ROSE group (P < .05, respectively). The cytopathological diagnostic cost of ROSE group was lower compared with non‐ROSE group (P < .05).ConclusionsEBUS‐GS‐TBLB combined with ROSE could be helpful to diagnose peripheral lung cancer, and could reduce the number of biopsy, procedure times, cytopathological diagnostic cost and complication.
Abstrac
Background
Rapid on‐site evaluation (ROSE) has the potential to increase endobronchial ultrasound (EBUS) guide transbronchial lung biopsy (TBLB) accuracy in the diagnosis of peripheral pulmonary lesions (PPLs). However, studies have reported controversial results. The aim of the study was to evaluate the diagnostic value of EBUS‐TBLB combination with ROSE in PPLs.
Methods
A total of 152 patients with PPLs underwent EBUS were enrolled and completed this study. Patients were divided into EBUS combined with ROSE group (EBUS+ROSE group) and EBUS group (EBUS group). The diagnostic yield, operation time, and complications were compared between the two groups.
Results
The diagnostic yield in EBUS+ROSE group was 85.9%, the operation time was (24.6 ± 6.8) min, the diagnostic yield in EBUS group was 70.3%, and the operative time was (32.4 ± 8.7) min, there were significant differences in diagnostic yield (χ2 = 5.456, P = .016) and operation time (t = 3.167, P = .001) between the two groups. No severe procedure related complications were observed, such as, pneumothorax and hemorrhage.
Conclusions
ROSE can improve the diagnostic yield and shorten the operation time. EBUS combined with ROSE is an effective diagnostic method for PPLs.
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