Ramucirumab plus paclitaxel as a second-line treatment in HER2-positive gastric cancer: subgroup analysis of a nationwide, real-world study in Korea (KCSG-ST19-16)

e15522 Background: This study aimed to explore the efficacy, safety of apatinib and analyze the effects of HER2 mutation status and treatment lines on gastric cancer (GC) patients (pts) treated with apatinib in real-world clinical practice. Methods: We retrospectively analyzed the study data from Linkdoc database with 270 pts who were pathologically or cytologically diagnosed GC and treated with apatinib during January 2015 to November 2018 in Henan Cancer Hospital. Survival was estimated by Kaplan-Meier method. Results: In this study, there were 180 (66.7%) male, with median age of 59 years. The vast majority of pts (259/95.9%) had adenocarcinoma and 86.3% of pts were in stage IV. HER2 was positive in 33.0% of 100 treated pts undergoing HER2 mutation testing. Apatinib was mainly used as second-line treatment (122/45.2%), followed by third-line (82/30.4%), first-line (56/20.7%), fourth- and further-line (22/8.1%), adjuvant (12/4.4%) and neoadjuvant treatment (1/0.4%). Pts received apatinib alone or combined with chemotherapy were 175 (64.8%) and 119 (44.1%), with 53.6% administered at an initial dose of 500 mg. Of all the 270 enrolled pts, the median progression free survival (mPFS) and median overall survival (mOS) were 4.3 months (95% CI: 3.5-5.0) and 6.1 months (95% CI: 5.1-8.4), respectively. For treatment lines subgroup, the mOS was 12.6 months (95% CI: 3.5-NE) in adjuvant treatment; 8.9 months (95% CI: 4.3-12.6) in first-line; 7.3 months (95% CI: 5.0-9.7) in second-line; 6.2 months (95% CI: 5.1-9.9) in third-line; 4.0 months (95% CI: 1.6-6.9) in fourth- and further-line treatment. For HER2-negative pts, the mOS was slightly longer than those of HER2-positive pts (5.7 months vs. 4.5 months), however, the difference was not statistically significant ( p = 0.5185). The most common adverse events were fatigue (25.9%), anemia (24.8%), hypertension (9.3%) and vomiting (9.3%). Conclusions: This real world study revealed that the clinical efficacy of apatinib in GC pts was satisfying and the toxicity was tolerable and controllable. Pts received apatinib in ≤ second-line treatment may gain better survival benefits, and little difference was found in survival outcomes between pts with or without HER2 mutations.

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Second-line treatment efficacy in elderly vs. non-elderly advanced gastric cancer patients: an Italian multicentre real-world study

Annals of Oncology ◽

10.1093/annonc/mdx425.004 ◽

2017 ◽

Vol 28 ◽

pp. vi45

Author(s):

V. Fanotto ◽

M. Uccello ◽

L. Fornaro ◽

L. Rimassa ◽

F. Leone ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Cancer Patients ◽

Real World ◽

Treatment Efficacy ◽

Line Treatment ◽

Second Line ◽

Gastric Cancer Patients

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Second-line treatment efficacy and toxicity in older vs. non-older patients with advanced gastric cancer: A multicentre real-world study

Journal of Geriatric Oncology ◽

10.1016/j.jgo.2018.11.009 ◽

2019 ◽

Vol 10 (4) ◽

pp. 591-597 ◽

Cited By ~ 1

Author(s):

Valentina Fanotto ◽

Lorenzo Fornaro ◽

Roberto Bordonaro ◽

Gerardo Rosati ◽

Lorenza Rimassa ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Real World ◽

Treatment Efficacy ◽

Older Patients ◽

Line Treatment ◽

Second Line

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Continuation of Trastuzumab Beyond Progression for Her2-Positive Advanced Gastric Cancer as Second-Line Treatment

Annals of Oncology ◽

10.1093/annonc/mdu435.39 ◽

2014 ◽

Vol 25 ◽

pp. v53

Author(s):

Yukiya Narita ◽

Shigenori Kadowaki ◽

Hiroya Taniguchi ◽

Daisuke Takahari ◽

Takashi Ura ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Line Treatment ◽

Second Line ◽

Her2 Positive

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Trastuzumab beyond progression in patients with HER2-positive advanced gastric adenocarcinoma: A multicenter AGEO study.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.4_suppl.94 ◽

2017 ◽

Vol 35 (4_suppl) ◽

pp. 94-94 ◽

Cited By ~ 3

Author(s):

Juliette Palle ◽

David Tougeron ◽

Astrid Pozet ◽

Emilie Soularue ◽

Pascal Artru ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Univariate Analysis ◽

Line Treatment ◽

Second Line ◽

First Line ◽

Her2 Positive ◽

Second Line Chemotherapy ◽

Platinum Based Chemotherapy ◽

Line Chemotherapy

94 Background: Trastuzumab in combination with platinum-based chemotherapy is the standard first line regimen in HER2 positive advanced gastric cancer. However, there is no data concerning continuation of trastuzumab beyond first line progression. Methods: This retrospective multicenter study include all consecutive patients with HER2 + advanced gastric or gastro-esophageal junction (GEJ) adenocarcinoma who received after progression of trastuzumab plus platinum-based chemotherapy, a second line chemotherapy with irinotecan, taxane or platinum salt, with or without trastuzumab. The prognostic variables with P values ≤0.10 in univariate analysis were eligible for the Cox multivariable regression model. Results: From August 2007 to March 2015, 104 patients were included (median age, 60.8 years; male, 78.8%; PS 0-1, 71.2%) with advanced (metastatic : 99%) gastric (45.2%) or GEJ (54.8%) cancer. All patients had received first line treatment based on trastuzumab plus fluoropyrimidine and cisplatin (n=54; 51.9%) or oxaliplatin (n=50; 48.1%). As second line chemotherapy, 67 patients (64.4%) received FOLFIRI regimen, including 19 who have continued trastuzumab; 23 patients (22.1%) received a taxane regimen (paclitaxel or docetaxel), including 12 with trastuzumab; and 14 patients (13.5%) received a platinum-based chemotherapy (different from that used in first-line), including 8 with trastuzumab. When considering all regimens of second-line chemotherapy, continuation (n=39) versus discontinuation (n=65) of trastuzumab was significantly associated with an increase on PFS (4.4 vs 2.3 months; p=0.002) and OS (12.6 vs 6.1 months; p=0.001). In multivariate Cox model (including ECOG PS, tumor grade, number of metastatic site, and second-line treatment), continuation of trastuzumab was significantly associated with longer PFS (HR=0.56; 95%CI [0.35-0.89]; p=0.01) and OS (HR=0.47; 95%CI [0.28-0.79]; p=0.004). Conclusions: This study suggests that maintenance of trastuzumab plus second line chemotherapy beyond disease progression has clinical benefit in patients with HER2 positive advanced gastric cancer. These results deserve a prospective randomized validation.

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Real-world evidence: A review of clinical experience in metastatic gastric cancer second-line treatment with ramucirumab

Gaceta Mexicana de Oncolog�a ◽

10.24875/j.gamo.m17000069 ◽

2019 ◽

Vol 16 (3) ◽

Author(s):

Miguel Quintana-Quintana ◽

María Consuelo Díaz-Romero ◽

Christian Patricio Camacho-Limas ◽

Laura Torrecillas-Torres ◽

Erika Ruiz-García ◽

...

Keyword(s):

Gastric Cancer ◽

Clinical Experience ◽

Real World ◽

Metastatic Gastric Cancer ◽

Line Treatment ◽

Second Line ◽

Real World Evidence

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Second-Line Treatment of HER2-Positive Gastric Cancer

Annals of Oncology ◽

10.1016/s0923-7534(20)32161-x ◽

2012 ◽

Vol 23 ◽

pp. xi76

Author(s):

Y. Hamamoto ◽

S. Funakoshi ◽

H. Higuchi ◽

H. Takaishi ◽

T. Hibi

Keyword(s):

Gastric Cancer ◽

Line Treatment ◽

Second Line ◽

Her2 Positive

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Lapatinib Plus Paclitaxel Versus Paclitaxel Alone in the Second-Line Treatment ofHER2-Amplified Advanced Gastric Cancer in Asian Populations: TyTAN—A Randomized, Phase III Study

Journal of Clinical Oncology ◽

10.1200/jco.2013.53.6136 ◽

2014 ◽

Vol 32 (19) ◽

pp. 2039-2049 ◽

Cited By ~ 299

Author(s):

Taroh Satoh ◽

Rui-Hua Xu ◽

Hyun Cheol Chung ◽

Guo-Ping Sun ◽

Toshihiko Doi ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Phase Iii ◽

Similar Proportion ◽

Line Treatment ◽

Second Line ◽

Her2 Positive ◽

Open Label ◽

Significant Difference ◽

Phase Iii Study

PurposeIn Asian countries, paclitaxel once per week is used as second-line treatment in advanced gastric cancer, including human epidermal growth factor receptor 2 (HER2) –positive tumors. The role of anti-HER2 agents, including lapatinib, in this setting and population is unclear.Patients and MethodsTyTAN was a two-part, parallel-group, phase III study in Asian patients. An open-label, dose-optimization phase (n = 12) was followed by a randomized phase (n = 261), in which patients who were HER2 positive by fluorescence in situ hybridization (FISH) received lapatinib 1,500 mg once per day plus once-per-week paclitaxel 80 mg/m2or paclitaxel alone. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), time to progression (TTP), overall response rate (ORR), time to response, response duration, and safety. Analyses were based on immunohistochemistry (IHC) and gastrectomy status, prior trastuzumab therapy, and regional subpopulations.ResultsMedian OS was 11.0 months with lapatinib plus paclitaxel versus 8.9 months with paclitaxel alone (P = .1044), with no significant difference in median PFS (5.4 v 4.4 months) or TTP (5.5 v 4.4 months). ORR was higher with lapatinib plus paclitaxel versus paclitaxel alone (odds ratio, 3.85; P < .001). Better efficacy with lapatinib plus paclitaxel was demonstrated in IHC3+ compared with IHC0/1+ and 2+ patients and in Chinese compared with Japanese patients. A similar proportion of patients experienced adverse events with each treatment (lapatinib plus paclitaxel, 100% v paclitaxel alone, 98%).ConclusionLapatinib plus paclitaxel demonstrated activity in the second-line treatment of patients with HER2 FISH-positive IHC3+ advanced gastric cancer but did not significantly improve OS in the intent-to-treat population.

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Evaluation of biosimilar trastuzumab MYL-1401O in HER2-positive early-stage and metastatic breast cancer in real-life data

10.21203/rs.3.rs-1146217/v1 ◽

2021 ◽

Author(s):

Kadir Eser ◽

Emel Sezer ◽

Vehbi Erçolak ◽

Ali İnal

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Targeted Therapy ◽

Neoadjuvant Chemotherapy ◽

Real World ◽

Metastatic Breast ◽

Line Treatment ◽

Second Line ◽

Cardiac Safety ◽

Her2 Positive

Abstract Background The trastuzumab biosimilar MYL-1401O has demonstrated equivalent efficacy and comparable safety to reference trastuzumab (RTZ) in clinical trials of human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) as non-dual HER2 therapy. Here, we present the first real-world comparison of MYL-1401O versus RTZ with single/dual HER2-targeted therapy for the neoadjuvant, adjuvan and palliative first-/second-line treatment with HER2-positive early breast cancer (EBC) and metastatic breast cancer (MBC) patients in two tertiary hospitals in Turkey. Methods We retrospectively investigated medical records in the Severance Breast Cancer Registry in Turkey. We identified patients with HER2-positive EBC (n=159) who had received neoadjuvant chemotherapy (n= 92) with RTZ or MYL-1401O±pertuzumab and adjuvant chemotherapy (n=67) with RTZ or MYL-1401O plus taxan between january 2018 and jun 2021. Stage IV MBC (n=53) who had received palliative first-line treatment with RTZ or MYL-1401O, and docetaxel±pertuzumab (THP) or second-line treatment with RTZ or MYL-1401O, and taxan between january 2018 and jun 2021. Primary endpoints were pathological complete response in neoadjuvant grup (pCR) and progression-free survival (PFS) in adjuvant and metastatic grup. Secondary endpoints in the metastatic patient group (MBC) was overall response rate (ORR), disease control rate (DCR) and cardiac safety. Results The rate of achieving pCR in the group receiving neoadjuvant chemotherapy was similar between MYL and RTZ (62.7% [37/59] and 55.9% [19/34] p=0.509). Median PFS similar in EBC-adjuvant group, 12-24-36 months PFS respectively 96.3%, 84.7%, 71.5% in patients with MYL and 100%, 88.5%, 64.8% in patients with RTZ (95% CI p=0.577). Median PFS similar in metastatic group, 23.0 (9.8-16.1) months in patients with MYL-1401O and 23 (19.9-26.0) months in patients with RTZ (95% CI p=0.270). The ORR, DCR, and cardiac safety profiles did not also show significant difference efficacy outcomes between two groups. Conclusion These real-world data suggest that biosimilar trastuzumab MYL-1401O has similar effectiveness and cardiac safety to RTZ in HER2-positive EBC and MBC patients when administered as part of single/dual HER2-targeted therapy with chemotherapy in the neoadjuvant, adjuvant or palliative setting.

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Trastuzumab-based palliative chemotherapy for HER2-positive gastric cancer: a single-center real-world data

BMC Cancer ◽

10.1186/s12885-021-08058-2 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Tae-Hwan Kim ◽

Hun Do Cho ◽

Yong Won Choi ◽

Hyun Woo Lee ◽

Seok Yun Kang ◽

...

Keyword(s):

Gastric Cancer ◽

Real World ◽

Group Performance ◽

Eastern Cooperative Oncology Group ◽

Conversion Surgery ◽

Single Center ◽

Her2 Positive ◽

Real World Data ◽

World Data ◽

The Real

Abstract Background Since the results of the ToGA trial were published, trastuzumab-based chemotherapy has been used as the standard first-line treatment for HER2-positive recurrent or primary metastatic gastric cancer (RPMGC). However, the real-world data has been rarely reported. Therefore, we investigated the outcomes of trastuzumab-based chemotherapy in a single center. Methods This study analyzed the real-world data of 47 patients with HER2-positive RPMGC treated with trastuzumab-based chemotherapy in a single institution. Results With the median follow-up duration of 18.8 months in survivors, the median overall survival (OS) and progression-free survival were 12.8 and 6.9 months, respectively, and the overall response rate was 64%. Eastern Cooperative Oncology Group performance status 2 and massive amount of ascites were independent poor prognostic factors for OS, while surgical resection before or after chemotherapy was associated with favorable OS, in multivariate analysis. In addition, 5 patients who underwent conversion surgery after chemotherapy demonstrated an encouraging median OS of 30.8 months, all with R0 resection. Conclusions Trastuzumab-based chemotherapy in patients with HER2-positive RPMGC in the real world demonstrated outcomes almost comparable to those of the ToGA trial. Moreover, conversion surgery can be actively considered in fit patients with a favorable response after trastuzumab-based chemotherapy.

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