Treatment patterns and outcomes in Chinese gastric cancer by HER2 status: A non-interventional registry study (EVIDENCE).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4025-4025
Author(s):  
Shukui Qin ◽  
Jiafu Ji ◽  
Rui-hua Xu ◽  
Wei Wang ◽  
Yong Tang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Real World ◽  
Progression Free Survival ◽  
Chinese Patients ◽  
Her2 Status ◽  
Line Treatment ◽  
Registry Study ◽  
First Line ◽  
Real World Data ◽  
First Line Treatment

4025 Background: Gastric cancer (GC) is the second leading cause of cancer-related deaths in China. Trastuzumab (TRA) has been used to treat HER2+ metastatic gastric cancer (mGC) in China since 2012. However, real-world data on effectiveness and safety in Chinese patients are limited. Methods: This prospective, multicenter (85 hospitals), real-world noninterventional registry study evaluated the effectiveness and safety of TRA in five cohorts of Chinese GC patients with different HER2 statuses from April 2013 to June 2018. Effectiveness analysis was conducted in three cohorts: Cohort I (HER2+ mGC with TRA), Cohort II (HER2+ mGC untreated with TRA) and Cohort IV (HER2− mGC untreated with TRA). Safety outcomes of TRA-related adverse events (AEs) were analyzed in Cohort I. Results: Cohorts I, II and IV included 709 patients (174, 113 and 422, respectively; mean age 57.8 years; 72% male); 64.9% of patients were ECOG 0–1, 93.7% had a primary GC tumor and 42.3% were at stage T4. Progressive disease was the cause of death in 32.8%, 27.4% and 29.9% in Cohorts I, II and IV, respectively. Respective mean duration of follow-up was 422.5, 287.5 and 277.5 days. Median overall survival (OS) was 22.3, 17.2 and 17.4 months, respectively. After excluding patients who had surgery, the respective median OS was 19.9, 15.3, and 12.6 months. For the first-line treatment, the median OS in Cohort I was 22.1 months, and the median progression free survival (PFS) was 8.2, 6.9 and 6.2 months in Cohorts I, II and IV, respectively. Response rates (RR) for first-line treatment in Cohorts I, II and IV were 51.7%, 18.4% and 32.8%, respectively. After propensity score matching, OS, PFS and RR were all significantly better in Cohort I versus II (all P<0.05). The most common regimen, TRA+XELOX (capecitabine+oxaliplatin), was estimated to have the longest median OS at 34.6 months. Grade ≥3 AEs were reported in 33.9% (59/174) of patients in Cohort I; anemia was the most common AE (12.1%). Conclusions: TRA improved OS and PFS in Chinese HER2+ mGC patients compared with chemotherapy alone and was well tolerated and effective when combined with a range of other therapies in a real-world setting. Clinical trial information: NCT01839500.

scholarly journals Real World First-Line Treatments and Outcomes of Nab-Paclitaxel Plus Gemcitabine, mFOLFIRINOX and GEMOX in Unresectable Pancreatic Cancer from a Chinese Single Institution

2020 ◽  
Vol 28 (1) ◽  
pp. 209-219
Author(s):  
Qi Quan ◽  
Yixing Wang ◽  
Fenghua Wang ◽  
Dongsheng Zhang ◽  
Xiuxing Chen ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Real World ◽  
Objective Response ◽  
Chinese Patients ◽  
Cancer Center ◽  
Unresectable Pancreatic Cancer ◽  
Line Treatment ◽  
First Line ◽  
Real World Data ◽  
First Line Treatment

Background: There have not been any head-to-head prospective studies to compare the effects of different chemotherapy regimens as first-line treatments for unresectable pancreatic cancer (UPC). We aimed to compare the effectiveness of nab-paclitaxel plus gemcitabine, mFOLFIRINOX and gemcitabine plus oxaliplatin (GEMOX) as first-line treatments by using real-world data from Chinese patients. Methods: We retrospectively included patients with UPC treated with nab-paclitaxel plus gemcitabine, mFOLFIRINOX or GEMOX as a first-line treatment at Sun Yat-sen University Cancer Center. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) were assessed. Results: A total of 117 patients were administered nab-paclitaxel plus gemcitabine (n = 62), mFOLFIRINOX (n = 30) or GEMOX (n = 25) as first-line chemotherapy. The median OS was 11.1, 10.1 and 10.2 months (p = 0.75) in the nab-paclitaxel plus gemcitabine, mFOLFIRINOX and GEMOX, respectively. The ORR was similar among the three groups (24%, 23% and 32%, p = 0.76) and the DCR was higher in the nab-paclitaxel-gemcitabine group (82%) than the other two groups (60% and 64%, p = 0.04). The most common adverse events of grade 3 or 4 were neutropenia (32%, 28% and 5%), peripheral neuropathy (13%, 16% and 0) and fatigue (9%, 16% and 5%). Febrile neutropenia occurred in 2%, 4% and 5% of the patients in the three groups. Conclusion: In the first line treatment of UPC, our results suggest that nab-paclitaxel plus gemcitabine was associated with a higher DCR than mFOLFIRINOX or GEMOX, while all groups demonstrated similar OS, PFS and ORR.

CML-296: First-Line Treatment Outcomes of CML Patients in a Real-World Data Setting in Lebanon

2021 ◽  
Vol 21 ◽  
pp. S332-S333
Author(s):  
Fadi Nasr ◽  
Intissar Yehia ◽  
Reem El Khoury ◽  
Saada Diab ◽  
Ahmad Al Ghoche ◽  
...  
Keyword(s):  
Treatment Outcomes ◽  
Real World ◽  
Line Treatment ◽  
First Line ◽  
Real World Data ◽  
World Data ◽  
First Line Treatment

Efficacy of pertuzumab in combination with trastuzumab and a taxane in first-line treatment for metastatic breast cancer (MBC): A multicenter, retrospective, observational study.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12504-e12504 ◽  
Author(s):  
Teresa Gamucci ◽  
Lucia Mentuccia ◽  
Isabella Sperduti ◽  
Alain Gelibter ◽  
Loretta D'Onofrio ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Observational Study ◽  
Real World ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Rank Test ◽  
Line Treatment ◽  
First Line ◽  
First Line Treatment

e12504 Background: Pertuzumab (P) , Trastuzumab (T) and Docetaxel (D) is standard first-line treatment in patients (pts) with HER2 + metastatic breast cancer (MBC). This multicenter retrospetive observational study was performed to evaluate the activity of P and T in combination with D or Paclitaxel (Tx) in real world HER2 + MBC pts. Methods: We identified HER2 + MBC pts treated with P, T and D or Ptx optionally followed by P, T and endocrine therapy (ET) maintenance in hormone positive (HR+) BC, in 17 Italian cancer centres between 09/2012 and 08/2016. Overall Survival (OS) and Progression Free Survival (PFS) were calculated by the Kaplan-Meier product-limit method. Log-rank test was used to assess differences between subgroups. Results: 191 pts were included in our analysis. Pts characteristics: median age 54 years (range 29-80); PS 0 in 127 (67%) pts and PS 1 in 54 (28%); 107 (56%) had visceral metastases (mts), 23 (12%) only bone mts and 28 (15%) brain mts, 130 (68%) were ER/PgR +. 76 pts (40%) were metastatic at diagnosis; 148 (78) were treated with D while 43 (22%) with Tx. The ORR was 78% (CI 95% 72-84), RC 18% and RP 60%, only 10 (5%) had PD. To date, of the 54 pts treated with ET maintenance, 26% had a further improvement of response (7 pts had RC). At median follow-up of 17 months (mo) (range 6- 52), median PFS was 20 mo (95% CI 14-26) and median OS at 2 years was 80%. No differences in PFS were found for age (p = 0.92), PS (p = 0.18), receptor status (p = 0.57), visceral mts (p = 0.54) and chemotherapy (cht) type (p = 0.47), whereas number of mts site (1 vs > 1) affected PFS (28 vs 16 mo, p = 0.002). Moreover median PFS in naïve pts and in pts pretreated with only cht was 28 mo (95% CI, 20-36) and 27 mo (95% CI, 16-38) respectively, whereas in pts pretreated with T it was 12 mo (95% CI 16-38 p 0.002). In HR+ pts ET maintenance together with P and T had an impact on PFS (28 vs 15 mo, p = 0.01). Conclusions: Our analysis confirms, in real world HER2 MBC pts, the efficacy of P, T and a taxane combination in first line treatment; in this population PFS was shorter in pts pretreated with T. ET maintenance in association with P and T in HR+ pts improved PFS. Data collection is ongoing and update results will be presented.

Progression-free survival as a predictor of overall survival in patients with advanced breast cancer: A real-world study from the China National Cancer Center.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12590-e12590
Author(s):  
Hongnan Mo ◽  
Binghe Xu ◽  
Fei Ma ◽  
Qing Li ◽  
Pin Zhang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Real World ◽  
Progression Free Survival ◽  
Advanced Breast ◽  
Line Treatment ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
First Line Treatment

e12590 Background: Use of progression-free survival (PFS) as a clinical trial endpoint in first-line treatment of patients with advanced breast cancer is attractive, but would be enhanced by establishing a correlation between PFS and overall survival (OS). Methods: From January 2003 to December 2012, 1851 patients with advanced breast cancer at start of first-line therapy were enrolled in this real-world study. An independent cohort of patients hospitalized in 2013 was used for external validation. All data were collected from the Database of China National Cancer Cancer. Results: The correlation coefficient (Pearson’s r) between PFS and OS was 0.807 in patients only receiving endocrine therapy as first-line treatment, 0.643 in those treated with chemotherapy, and 0.642 in the whole cohort. Receiver operating characteristic curve indicated that PFS = 12 months was the optimal cutoff value for predicting patient’s survival. The median OS was 30.0 months (95% CI 27.8-32.2) in the PFS < 12 months group, and 69.0 months (95% CI 60.8-77.2) in the other group (P < 0.0001). Multivariate analysis revealed that compared with patients who did not progress at 12 months, the adjusted hazard ratio (HR) for death was 2.681 (95% CI, 2.301-3.124; P < 0.0001) for patients with PFS < 12 months. Subgroup analysis based on patient’s age, molecular subtype, visceral metastasis and types of first-line treatment further confirmed that PFS < 12 months was associated with significant poor prognosis in all these subgroups. In patients with luminal type of breast cancer, the HR for death was 2.567 (95%CI 2.147-3.069; P < 0.0001) for patients with PFS < 12 months. Notably, for these patients with luminal type breast cancer who had progressed within 12 months after first-line treatment, addition of chemotherapy in the second-line therapy would surprisingly have adverse effects on patients’ survival when compared with endocrine therapy alone (HR = 1.627, 95%CI 1.016-2.604, P = 0.043). The findings were externally validated in the independent cohort. Conclusions: To our knowledge, this is the first real-world study revealed that PFS at 12 months in first-line therapy predict OS of patients with advanced breast cancer.

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