Gefitinib as third-line re-challenge treatment in advanced NSCLC patients with EGFR activating mutation who benefited from first-line gefitinib treatment followed by second-line chemotherapy.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9035-9035
Author(s):  
Yong Song ◽  
Yi-Long Wu ◽  
Lejie Cao ◽  
Jianhua Chen ◽  
Zhiyong Ma ◽  
...  

9035 Background: Several studies show that EGFR-mutant NSCLC patients (pts) gained response to EGFR-TKI treatment again after a TKI free interval. To date, no prospective evaluation of the clinical effects of EGFR-TKI re-challenge in EGFR-mutant NSCLC pts has been performed. Methods: This was a multicenter, open-label, single-arm, phase II study (CTONG1304, NCT01933347). Stage IIIB/IV NSCLC pts with EGFR exon 19del/L858R mutation, who previously benefited from first-line gefitinib treatment followed by second-line chemotherapy, took gefitinib 250mg/d until disease progression or death or intolerable toxicity occurred. Blood samples were dynamically collected for EGFRmutation testing using droplet digital PCR at every visit (from baseline to the end of gefitinib treatment). The primary objective was disease control rate (DCR) at week 8. Secondary objectives were objective response rate (ORR), progression free survival (PFS), and overall survival (OS). Results: From March 2014 to May 2016, 45 eligible pts were enrolled and 43 pts were included in the full analysis set (FAS) for efficacy analysis. Gefitinib re-challenge achieved DCR of 69.8%. ORR was 4.7%. Median PFS and OS were 4.4 and 8.0 months (m) respectively. T790M- subgroup at baseline had higher DCR, longer mPFS and mOS, compared with T790M+ subgroup. EGFRstatus changed significantly after gefitinib re-challenge. Conclusions: Gefitinib re-challenge was an effective option in EGFR-mutant NSCLC pts. T790M negativity is a potentially predictive efficacy biomarker for gefitinib re-challenge. Clinical trial information: NCT01933347. [Table: see text]

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15613-e15613
Author(s):  
Young Saing Kim ◽  
Moon Ki Choi ◽  
Jung Yong Hong ◽  
Chi Hoon Maeng ◽  
Soonil Lee ◽  
...  

e15613 Background: Despite high response rates (RRs) with first-line platinum-based chemotherapy in advanced urothelial carcinoma (UCC), treatment after first-line failure remains unclear. The present multi-center phase II trial evaluated the tolerability and efficacy of weekly docetaxel as second-line chemotherapy for UCC. Methods: Between Aug 2010 and Sep 2012, 31 patients with measurable UCC, progressive after one prior platinum-based chemotherapy for advanced disease, were treated with docetaxel 30 mg/m2 on days 1 and 8. Treatment was repeated every 21 days until disease progression or unacceptable toxicity. The primary endpoints were the RR, progression-free survival (PFS), and safety. To detect a 20% difference in RR (6% vs. 26%), 28 eligible patients were required. Results: All 31 patients were previously treated with gemcitabine/platinum and had Bellmunt risk of one or more. The patients’ median age was 64 years (range, 40 to 79) and 31 (100%) patients had an ECOG performance status of 1. A total of 106 (median, 2; range, 1 to 16) chemotherapy cycles were delivered. Although fatigue (13%) and anorexia (6%) were the most frequently observed grade 3 or 4 toxicities, safety profiles were generally mild and manageable. One patient developed prolonged thrombocytopenia which led to treatment discontinuation but was resolved thereafter. In an intent-to-treat analysis, two (6%) patients achieved objective response, which maintained for 3.0 to 7.8 months. Eight patients experienced disease stabilization, resulting in a disease control rate of 32%. The median PFS and overall survival were 1.4 (95% CI, 1.3 to 1.6) and 9.6 (95% CI, 7.8 to 11.4) months, respectively. Conclusions: Second-line chemotherapy with weekly docetaxel was well tolerated but demonstrated modest antitumor activity in patient with advanced UCC who had progression after first-line platinum-containing regimen and poor prognostic factors. Clinical trial information: NCT01711112.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e20591-e20591
Author(s):  
Fengchun Mu ◽  
Bingjie Fan ◽  
Butuo Li ◽  
Wenru Qin ◽  
Xinyu Fan ◽  
...  

e20591 Background: The main aim of this study was to evaluate the efficiency of albumin-bound paclitaxel (nab-PTX) plus PD-1/PD-L1 inhibitor versus second-line chemotherapy in small cell lung cancer (SCLC) patients who have failure to the first-line standard treatment. Methods: We retrospectively collected patients’ data from medical records between January 2015 to July 2020 in Shandong Cancer Hospital and Institute. Consecutive 42 patients who were treated with nab-PTX plus PD-1/PD-L1 inhibitor were enrolled and compared with, 126 patients who received second-line chemotherapy (1:3 matched with patient and tumor characteristics). Progress free survival (PFS), overall survival (OS), objective response rate (ORR) and disease control rate (DCR) were evaluated for each group. Results: Patients treated with nab-PTX plus immunotherapy group and second-line chemotherapy group achieved the median PFS of 5.6 months and 3.3 months ( p = 0.043), respectively. The median OS were 7.7 months and 6.3 months ( p = 0.021), respectively. The ORR and DCR were also higher in nab-PTX plus PD-1/PD-L1 inhibitor group (ORR: 33.3% vs 20.6%, p = 0.094; DCR: 61.9% vs 41.3%, p = 0.020, respectively). The most common incidences of grade ≥3 adverse events were leukopenia and neutropenia, there were no significance difference between the two groups. Conclusions: Albumin-bound paclitaxel plus PD-1/PD-L1 inhibitor conferred higher ORR and DCR, and improved PFS and OS in SCLC patients failed with first-line treatment. Further prospective and randomized trial that directly compares the treatments is urgently warranted.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16080-e16080
Author(s):  
Ting Deng ◽  
Le Zhang ◽  
Jingjing Duan ◽  
Hongli Li ◽  
Shaohua Ge ◽  
...  

e16080 Background: Patients with advanced gastric or gastro-esophageal junction cancer have poor prognosis after progression on first-line chemotherapy. We investigated to combine second-line chemotherpy with third-line drugs, apatinib and anti-PD-1 antibody in these patients. Methods: This study is a single center, exploratory study in China. Eligible patients are adults with histologically confirmed advanced gastric or GEJ adenocancinoma, who were failure of first-line or second-line chemotherapy. Subjects receive chemotherapy, pacitaxol or iritecan (investigator choice), apatinib 250mg po qd, sintilimab 200mg ivd q3w. Response was assessed every 6 weeks. (RECIST version1.1) Primary endpoint was progression free survival (PFS). Results: Between May 30, 2019 and November 5, 2020, a total of 26 patients were enrolled in this study, and 4 (15.4%) patients were failure of second-line chemotherapy. There were 21 males and 5 females, and the median age was 61. The total number of treatment cycles was 140 and the median number was 5.5. Among 24 patients who were evaluated, partial response (PR) was obtained in 12 cases, stable disease (SD) in 8 cases and progressive disease (PD) in 4 cases. Objective response rate was 50.0%,and disease control rate was 83.3%. The median PFS was 7.06 months (95% CI 5.52-8.60), and the median overal survival has not yet been reached. The most common adverse events (AE) were leukopenia (61.5%), anemia (57.7%), neutropenia (53.8%), proteinuria (42.3%), alopecia (42.3%), hypothyroidism (38.5%), elevated alanine aminotransferase (34.6%), elevated aspartate aminotransferase (34.6%) and elevated alkaline phosphatase (34.6%), but most of them were grade 1 or 2, and the most common grade 3 or 4 treatment-related adverse events was neutropenia (11.5%). Conclusions: Chemotherapy, plus apatinib and sintilimab demonstrated promising activity and manageable safety profile as second- even third-line treatment in advanced gastric or GEJ cancer. Demographics and baseline characteristics.[Table: see text]


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20531-e20531
Author(s):  
Zhen-Yu Ding ◽  
Yue-Yun Chen

e20531 Background: Both EGFR-TKI and pemetrexed doublet chemotherapy (P) are two effective therapies in advanced NSCLC patients with EGFR mutant tumors. But which one should be used in first-line remains controversial. Methods: This was a retrospective study where patients prescribed with EGFR-TKI (gefitinib or icotinib) from Jan 2013 to Jan 2016 were screened. Patients must have metastastic diseases harboring TKI-sensitizing EGFR mutation. They must be older than 18 years, and have evaluable target lesions. Whether TKI or P was used in the first line, it must be switched to the other in the second line. PFS in both first line (PFS1) and second line (PFS2) was collected. Results: We screened totally 550 patients (gefitinib n = 455, icotinib n = 95) to enroll a cohort of 36 patients. They were all adenocarcinoma except 1 adenosquamous carcinoma. Gender (M or F), PS (0 or 1), mutation type (Exon19Ddel or other) were equally distributed. The median age was 50.5 years. For the whole cohort, the total PFS (PFS1+PFS2) was 18.1 m (95%CI: 15.2-21.1 m). For those (n = 24) receiving first-line TKI, PFS1, PFS2, and total PFS were 10.3 m, 6.6 m, and 19.2 m. And for those receiving first-line P (n = 12), they were were 3.4 m, 11.5 m, and 16.5m. The total PFS in both groups did not differ significantly (p = 0.548). Conclusions: Our results argued the sequential usage of TKI and P achieve a comparable PFS irrespective of the sequence.


2012 ◽  
Vol 6 (1) ◽  
pp. 3 ◽  
Author(s):  
Emmad E. Habib ◽  
Amr T. El-Kashef ◽  
Ezzat S. Fahmy

Neuroblastoma is a high-grade malignancy of childhood. It is chemo- and radio-sensitive but prone to relapse after initial remission. The aim of the current study was to study the results of the first- and second-line chemotherapy on the short-term response and long-term survival of children, and to further describe the side effects of treatment. Ninety-five children with advanced neuroblastoma were included in the study, divided into two groups according to the treatment strategy: 65 were treated by first-line chemotherapy alone, and 30 children who were not responding or relapsed after first-line chemotherapy were treated by second-line chemotherapy. External beam radiotherapy was given to bone and brain secondary cancers when detected. Staging workup was performed before, during and after management. Response was documented after surgery for the primary tumor. Median follow up was 32 months (range 24-60 months). Chemothe rapy was continued until toxicity or disease progression occurred, indicating interruption of chemotherapy. Patients received a maximum of 8 cycles. Toxicity was mainly myelo-suppression, with grade II-III severity in 60% of the firstline and 70% of the second-line chemotherapy patients. Median total actuarial survival was nearly 51 months for the first-line chemotherapy group and 30 months for the second-line line group, with a statistically significant difference between the two groups (P<0.01).


Oncology ◽  
2018 ◽  
Vol 96 (3) ◽  
pp. 140-146 ◽  
Author(s):  
Dai Inoue ◽  
Shuhei Sekiguchi ◽  
Wataru Yamagata ◽  
Gen Maeda ◽  
Daiki Yamada ◽  
...  

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