scholarly journals Real Life Experience of Patients With Locally Advanced Gastric and Gastroesophageal Junction Adenocarcinoma Treated With Neoadjuvant Chemotherapy: a Turkish Oncology Group Study

2021 ◽  
Author(s):  
Tugba Basoglu ◽  
cihan erol ◽  
abdullah sakin ◽  
ercan özden ◽  
devrim çabuk ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Life Experience ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Real Life ◽  
Disease Free Survival ◽  
R0 Resection ◽  
Toxicity Profile ◽  
Life Study ◽  
Gastroesophageal Junction Adenocarcinoma

Abstract PurposeNeoadjuvant chemotherapy(NACT) in gastroesophageal junction(GEJ) and gastric cancer(GC) was shown to improve survival in recent studies. We aimed to share our real-life experience of patients who received NACT in order to compare the efficacy and toxicity profile of different chemotherapy regimens in our country.Methods This retrospective multicenter study included locally advanced GC and GEJ cancer patients who received NACT, and had pathological response evaluation between 2007 and 2021. Relation between CT regimens and pathological evaluation were analyzed. Results A total of 728 patients from 45 oncology centers in Turkey were included. Median age at the time of diagnosis was 60 (range: 18-68). Most frequent NACT regimens used were FLOT (65%), DCF (18%) and ECF (8.1%), respectively. In the total study group pCR rate was 8.2%, R0 resection rate 88.5%, and D2 dissection rate was 66.8%. Rate of pCR and near-CR (26.4%), and R0 resection (92.6%) were higher in FLOT arm (p= 0.005 and <0.001). Patients who received FLOT had significantly higher chemotherapy-related toxicity rate compared to patients who received other regimens (p=0.02).Median follow-up time was 17 months (range: 3-106 months). Estimated median overall survival (OS) was 59.4 months (95% CI: 32.9-86.0) and disease-free survival (DFS) was 47.6 months (95% CI: 24.4-70.8). The highest 5-year estimated OS rate was also shown in FLOT arm (58%). ConclusionIn our real-life study, FLOT regimen has superior survival outcome despite worse toxicity profile. Clinicians should tailor treatment regimens according to patients’ multifactorial status and comorbidities for to obtain best outcomes.

Phase II study of perioperative toripalimab in combination with FLOT in patients with locally advanced resectable gastric/gastroesophageal junction (GEJ) adenocarcinoma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4050-4050
Author(s):  
Hongli Li ◽  
Jingyu Deng ◽  
Shaohua Ge ◽  
Fenglin Zang ◽  
Le Zhang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Phase Ii ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Death Receptor ◽  
Disease Free Survival ◽  
Complete Response ◽  
R0 Resection ◽  
Combination Regimen

4050 Background: FLOT is the standard perioperative treatment for resectable gastric /gastroesophageal junction (GEJ) adenocarcinoma. However, patient’s outcome is still poor. Toripalimab, a humanized IgG4 monoclonal antibody against programmed cell death receptor-1 (PD-1), has shown remarkable clinical efficacy in various cancers. This trial evaluates the addition of Toripalimab to FLOT for resectable patients. Methods: This is a prospective, single-arm, investigator-initiated phase II trial. Patients with histologically confirmed, resectable, gastric and GEJ adenocarcinoma (≥cT2 or cN+) were enrolled to receive 4 pre-and post-operative cycles of toripalimab (240mg, q2w) plus FLOT (docetaxel 50 mg/m2; oxaliplatin 85 mg/m2; leucovorin 200 mg/m2; 5-FU 2600 mg/m2, q2w). The primary endpoint was pathological complete response rate (pCR). The secondary endpoints included major pathological (complete and nearly complete) response (MPR), and R0-resection rate, 3-year disease-free survival rate, overall survival, and adverse events. Results: In total, of 36 patients were enrolled from June 2019 through Dec 2020. Male, 66.7%; median age, 60y; cT3 8.3%, T4, 83.3%; cN+ 88.9%; GEJ 47%; MSI-H, 5.6%, Her-2neu-positive, 5.6%, EBER-positive, 5.6%). Two patients refused surgery, six patients have not yet completely neoadjuvant treatment. 100% of patients completed the 4 pre-cycle. Patients who had received gastrectomy after neoadjuvant treatment (n=28) were included in this analysis. 6 (21%) patients had operations involving a thoracic approach (oesophagogastrectomy with two field lymphadenectomy), 21 (75%) gastrectomy with D2 lymphadenectomy. 8 (29%) evaluable patients had Clavien-Dindo grade II post-operative complications and 2 (7%) grade IIIA complications; one patient had an anastomotic leakage that was treated endoscopically. There were no emergency re-operations. All 28 patients achieved R0-resection and were discharged home after a median of 12 days (range:7-63) in hospital. 7 （25%）patients achieved pCR (TRG1a) and 12 (42.9%) patients achieved major pathologic response (MPR, TRG1a/b). Treatment-related adverse events (TRAEs) to any drug were reported in 30 (94%) patients. Mostly TRAEs were grade 1-2, the grade 3 or 4 TRAEs included neutropenia (34%), neutropenia (25%), lymphopenia (3%), Alanine aminotransferase increased (3%), hypokalemia (3%) and anaemia (3%). Conclusions: Perioperative toripalimab in combination with FLOT showed promising efficacy with high pCR and MPR rate and well tolerated safety profile in patients with resectable gastric/GEJ adenocarcinoma. This combination regimen might present a new option for patients with locally advanced, resectable gastric/GEJ adenocarcinoma. Clinical trial information: NCT04354662.

A single-arm, phase II feasibility study of neoadjuvant docetaxel, oxaliplatin, and S-1 (DOS) chemotherapy in potentially resectable gastric or gastroesophageal junction adenocarcinoma.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 96-96
Author(s):  
M. Ryu ◽  
Y. Choi ◽  
B. Kim ◽  
Y. Park ◽  
H. Kim ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Gastric Cancer ◽  
Residual Disease ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Phase Iii ◽  
R0 Resection ◽  
Locally Advanced Gastric Cancer ◽  
Grade 3

96 Background: The aim of this study was to evaluate feasibility and safety of neoadjuvant docetaxel, oxaliplatin, and S-1 (DOS) chemotherapy in patients with potentially resectable adenocarcinoma of stomach or gastroesophageal junction. Methods: Forty-one patients with clinical stage T3-4N0M0 or T2-4N+M0 determined by CT, endoscopic ultrasonography, and laparoscopy were enrolled between DEC 2008 and MAR 2010. Gastrectomy with D2 lymph node dissection was conducted after 3 cycles of DOS chemotherapy. DOS chemotherapy consists of docetaxel 50 mg/m2 iv (day1), oxaliplatin 100 mg/m2 iv (day1), and S-1 40 mg/m2 po bid (days1-14) at 3 weeks interval. After curative gastrectomy, the patients were given 1 year of adjuvant chemotherapy with S-1 (40 mg/m2 D1-28, every 6 weeks). Results: All patients finished the planned neoadjuvant chemotherapy. Twenty-three (56%) patients achieved a partial response, and the remaining 18 patients had stable disease by CT scan after 3 cycles of DOS chemotherapy. No disease progression was observed during the neoadjuvant chemotherapy. A median 4.7 weeks (range, 4.0-7.6) after the start of the 3rd cycle of DOS chemotherapy, 39 (95%) patients underwent R0 resection with no pathologic residual disease in 4 (10%) patients. Hematologic toxicities were common including grade 4 neutropenia (32%), grade 3 thrombocytopenia (17%), and febrile neutropenia (10%). However, hematologic toxicities were generally transient and manageable. There were no grade 3 or 4 non-hematologic toxicities with frequency > 5% of patients. With all toxicities taken together, 21 (51%) patients experienced grade 3 or 4 toxicities (except grade 3 neutropenia). There was no treatment-related death, and surgical complications included only mild wound problem in 4 (10%) patients. Conclusions: In this study, neoadjuvant DOS chemotherapy could induce a sufficient down-staging and R0 resection of locally advanced gastric cancer with mild and manageable toxicities. A phase III randomized trial is planned for evaluating the benefit of neoadjuvant DOS chemotherapy in patients with locally advanced gastric cancer. [Table: see text]

A phase II study of weekly nab-paclitaxel in combination with cisplatin as neoadjuvant chemotherapy in patients (pts) with locally advanced esophageal squamous cell carcinoma (SCC).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 122-122
Author(s):  
Fan Yun ◽  
Xinming Zhou ◽  
Youhua Jiang ◽  
Qixun Chen ◽  
Zhiyu Huang ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Response Rate ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Pathological Response ◽  
R0 Resection ◽  
Resection Rate ◽  
Free Survival ◽  
Disease Free

122 Background: This phase II study was aimed to define the pathological response rate and safety of combining weekly nab-paclitaxel and cisplatin as neoadjuvant chemotherapy in pts with locally advanced esophageal SCC. Methods: Pts with resectable locally advanced thoracic esophageal SCC staged by EUS, CT and/or PET-CTscan. All pts received nab-paclitaxel (100 mg/m2, d1, d8, d22 and d29) and cisplatin (75 mg/m2, d1 and d22) as neoadjuvant chemotherapy, followed by esophagectomy.Postoperation: 2 cycles of adjuvant chemotherapy with same regimen was given in 4-6 weeks after the resection.The primary endpoint was pathological response rate. The second endpoints included R0 resection rate,down-staging rate, 3 years overall survival (OS) and disease-free survival (DFS). Results: From 01/2011 to 10/2012, 35 pts were enrolled. 31 male:4 females; IIA/IIB/IIIA/IIIB/IIIC in 3 (8.6%), 5 (14.3%),10 (28.6%), 8 (22.9%) and 9 (25.7%) pts. 30/35 pts went to surgery (85.7%). 30 had R0 resection (100%). Pathological complete response (pCR) was achieved in 4 pts (13.3%). Near pCR (microfoci of tumor cells on the primary tumor without lymph nodal metastases) in 2 pt (6.7%). Down-staging was observed in 19 of 30 patiens (63.3%). 5 pts did not going to surgery: 2 for progressive disease, 3 for refused. 24/30 pts (80.0%) received adjuvant chemotherapy, 7 pts (23.3%) received adjuvant chemoradiotherapy. Grade 3/4 toxicities in 35 evaluable pts during chemotherapy were as follow: neutropenia (11.4%), anemia (8.6%), thrombocytopenia (5.7%), nausea/vomiting (14.3%), neutropenia fever (8.6%), asthenia (20.0%). Surgical complications: 1 anastomotic leaks (3.3%). No treatment-related death. At a median follow up of 12 months (8~20mos), 29 pts were all disease-free survival. Conclusions: In pts with locally advanced esophageal SCC, weekly nab-paclitaxel and cisplatin as neoadjuvant chemotherapy achieved a high pathological response rate and R0 resection rate. The toxicity was well tolerated. Evaluation of nab-paclitaxel and cisplatin in randomized trials was warranted. Clinical trial information: NCT01258192.

A randomized phase II study evaluating efficacy and safety of SOX versus mFOLFOX6 as neoadjuvant chemotherapy for patients with resectable rectal cancer (KSCC1301).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 3549-3549
Author(s):  
Kenji Katsumata ◽  
Eiji Oki ◽  
Hiroyuki Kato ◽  
Keisuke Miwa ◽  
Masahiko Sugiyama ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Phase Ii ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
R0 Resection ◽  
Severe Toxicity ◽  
Efficacy And Safety ◽  
Neoadjuvant Radiotherapy ◽  
Randomized Phase Ii

3549 Background: Neoadjuvant radiotherapy is the current standard of care for rectal cancer. However, radiation therapy is sometimes associated with short-term severe toxicity and long-term morbidity. Perioperative introduction of new chemotherapy agents without radiotherapy for locally advanced rectal cancer (LARC) may be a promising option. Several studies of combination chemotherapy with oxaliplatin plus S-1 (SOX) have reported promising efficacy and safety in patients with metastatic colorectal cancer, suggesting a potential replacement for mFOLFOX6. Methods: A randomized phase II trial was undertaken to compare the efficacy and safety of SOX and mFOLFOX6 as neoadjuvant chemotherapy for patients with LARC. Patients were randomly assigned to receive mFOLFOX6 (every 2 weeks; day 1: 400 mg/m2 bolus 5-fluorouracil [5-FU]; days 1 and 2: 2,400 mg/m2 continuous 5-FU; day1: 200mg/m2 l-LV; and day 1: 85 mg/m2 oxaliplatin) or SOX (every 3 weeks; days 1–14: 80 mg/m2 oral S-1; and day 1: 130 mg/m2oxaliplatin). The protocol period for neoadjuvant chemotherapy was 3 months. The primary endpoint was the 3-year disease-free survival rate (3y DFS), and the secondary endpoints included pathological effect, R0 resection rate, survival and safety. Results: Between September 2013 and October 2015, 110 patients were enrolled and randomized (56 received SOX and 54 received mFOLFOX6). Baseline characteristics were balanced between the two arms. The major adverse events were neutropenia, peripheral neuropathy, loss of appetite, and fatigue. The incidence of grade 3 or higher neutropenia based on the CTCAE Vers.4.0was 13.2% in the SOX group and 32.0% in the mFOLFOX6 group. The surgical completion rate was 100% for the SOX group and 96% for the mFOLFOX6 group. The incidence of grade II or more surgical site infection based on Clavien-Dindo classification (CD) was 11.3% and 4.2% for the SOX and mFOLFOX6 groups, respectively. The CD grade III anastomosis-related complications developed in 7 cases in total. Conclusions: The KSCC1301 study suggests that neoadjuvant chemotherapy without radiation is active and safe. The results of pathological response will be provided. Clinical trial information: UMIN000011486.

Efficacy and safety of camrelizumab combined with FOLFOX as neoadjuvant therapy for patients with resectable locally advanced gastric and gastroesophageal junction adenocarcinoma who received D2 radical gastrectomy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16549-e16549
Author(s):  
Yuzhou Zhao ◽  
Guangsen Han ◽  
Jing Zhuang ◽  
Zhimeng Li ◽  
Gangcheng Wang ◽  
...  
Keyword(s):  
Lymph Node ◽  
Neoadjuvant Therapy ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
R0 Resection ◽  
Lymph Node Yield ◽  
D2 Lymph Node Dissection ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
The Mean

e16549 Background: Neoadjuvant chemotherapy for patients with locally advanced gastric and gastroesophageal junction adenocarcinoma (GC/GEJC) can improve the overall survival without increasing operation risk. Nowadays, immunotherapy has become a new promising neoadjuvant treatment. Therefore, we intended to evaluate the safety and efficacy of camrelizumab (anti-PD-1 antibody) combined with FOLFOX as the neoadjuvant therapy for patients with locally advanced GC/GEJC who received D2 radical gastrectomy. Methods: Patients who were diagnosed as resectable locally advanced GC/GEJC received the neoadjuvant treatment of camrelizumab and FOLFOX every 2 weeks for 4 cycles. Imaging evaluation was performed in 2-4 weeks after neoadjuvant therapy. Patients who had no progression disease (PD) were recruited. Eligible patients underwent gastrectomy with D2 lymph node dissection through laparotomy or laparoscopic surgery. The primary end points were safety and R0 resection rate. Results: From July 24 2019 to January 31 2020, 15 patients were recruited. The mean age was 57 years. A total of 10(67%) were males and 5(33%) were females. According to AJCC 8th, cT3 and cT4 were confirmed in 7(47%) patients and 8(53%) patients, N1 and N2 in 7(47%) patients and 8(53%) patients, respectively. During operation, intraperitoneal metastases were found in 2 patients. Of the 13 surgeries, only 2 were laparoscopic and the others were laparotomy. The surgical procedures included Roux-en-Y (9, 69.2%), Billroth II (1, 7.7%) and jejunum interposition (3, 23.1%). Thirteen patients underwent gastrectomy with D2 lymph node dissection and all of them were confirmed R0 resection by postoperative pathology results. The mean lymph node yield was 44.1±13.2 nodes, positive lymph node yield was 1.8±2.8 nodes. Duration time of surgery was 186.5±45.5 minutes, mean blood loss was 219.2±109 ml during the operation. Mean hospital stays were 13.2±2.4 days. Only 1 patient experienced grade 3 pneumonia. Neither serious intraoperative complications nor immune-related adverse events both prior and post operation were observed. There was no treatment-related death. Conclusions: Camrelizumab combined with FLOFOX as neoadjuvant treatment for patients with locally advanced GC/GEJC showed acceptable toxicity and promising efficacy with low complications and mortality. Clinical trial information: NCT03939962 .

Camrelizumab combined with FOLFOX as neoadjuvant therapy for resectable locally advanced gastric and gastroesophageal junction adenocarcinoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4536-4536
Author(s):  
Ying Liu ◽  
Guangsen Han ◽  
Hongle Li ◽  
Yuzhou Zhao ◽  
Jing Zhuang ◽  
...  
Keyword(s):  
Neoadjuvant Therapy ◽  
Clinical Stage ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Complete Response ◽  
R0 Resection ◽  
Radical Gastrectomy ◽  
Imaging Evaluation ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
Ecog Ps

4536 Background: Neoadjuvant chemotherapy has been demonstrated to improve the pathological complete response(pCR) and 5-year survival rate of patients with locally advanced gastric and gastroesophageal junction adenocarcinoma (GC/GEJC). Immunotherapy has become a new promising treatment for advanced GC/GEJC. Therefore, we intended to evaluate the safety and efficacy of Camrelizumab (anti-PD-1 antibody) combined with FOLFOX as the neoadjuvant therapy for patients with locally advanced GC/GEJC. Methods: Eligiblepatients were locally advanced GC/GEJC with clinical stage≥T2 and/or positive lymphoglandula confirmed by endoscopic ultrasonography (EUS) and imaging. They received 4 cycles neoadjuvant therapy which including Camrelizumab(200mg ivgtt D1), FOLFOX(Oxaliplatin 85mg/m2 ivgtt D1, 5-Fu 400mg/m2 iv D1, LV 200mg/m2 ivgtt D1, 5-Fu 2.4mg/m2 CIV 46 hours) every 14 days. Imaging evaluation was performed in 2-4 weeks after neoadjuvant therapy. Patients without progression disease (PD) received D2 radical gastrectomy. The primary endpoint was pCR, the secondary endpoints were R0 resection rate and safety. Results: From July 24 2019 to January 31 2020, 16 patients were eligible. The median age was 57 years (29-72 years). A total of 11(69%) males and 5(31%) females, ECOG PS 0 (n=9, 56%), ECOG PS 1 (n=7, 44%). All the patients completed 4 cycles treatment and none of them was confirmed PD by image. One of the patients refused gastrectomy and withdraw from the study. The other 15 patients underwent operation. Unfortunately, intraperitoneal metastases were confirmed in 2 patients during operation. 13 patients received D2 radical gastrectomy and all of them experienced R0 resection. Among the 13 evaluable patients, 1 patient (8%) was observed pCR, 3 patients (23%) experienced TRG1, 10 patients (77%) achieved stage reduction. Notably, 8 patients (62%) had lymphonodus pCR. The grade 3-4 treatment-related AEs were neutropenia (n=3, 19%), leukopenia (n=2, 13%) and anorexia (n=1, 6%). No serious AEs resulted in termination of treatment. Either severe immune-related AEs or treatment-related death was not observed. Conclusions: Camrelizumab combined with FOLFOX as neoadjuvant regimen in patients with locally advanced GC/GEJC showed promising pCR with good tolerance. Clinical trial information: NCT03939962 . [Table: see text]

Camrelizumab combined with FLOFOX as neoadjuvant therapy for resectable locally advanced gastric and gastroesophageal junction adenocarcinoma: Updated results of efficacy and safety.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4036-4036
Author(s):  
Ying Liu ◽  
Guangsen Han ◽  
Hongle Li ◽  
Yuzhou Zhao ◽  
Zhi Li ◽  
...  
Keyword(s):  
Neoadjuvant Therapy ◽  
Clinical Stage ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
R0 Resection ◽  
Efficacy And Safety ◽  
D2 Lymph Node Dissection ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
Therapy Strategy ◽  
Grade 3

4036 Background: Although anti-PD-1 antibody in combination with chemotherapy has shown promising antitumor activity in advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC), the evidence of neoadjuvant therapy for locally advanced GC/GEJC is limited. Camrelizumab combined FOLFOX as neoadjuvant therapy for resectable locally advanced GC/GEJC was a prospective, single-arm, phase 2 study we conducted. Here, we updated the results of efficacy and safety of this study. Methods: Patients confirmed by endoscopic ultrasonography (EUS) and imaging with clinical stage≥T2 and/or positive lymph nodes were enrolled. They received 4 cycles of camrelizumab (200mg ivgtt on day1, q2w) plus FOLFOX (oxaliplatin 85mg/m2 ivgtt, LV 200mg/m2 ivgtt, 5-Fu 400mg/m2 iv followed by 2.4mg/m2 CIV 46 hours on day 1, q2w) as neoadjuvant therapy. Then patients without disease progression evaluated by imaging underwent gastrectomy of D2 lymph node dissection. The primary endpoint was pCR, the secondary endpoints were R0 resection rate and safety. Results: Between Jul 24 2019 and Nov 30 2020, 49 patients were enrolled. The median age was 57 years (29-72 years). All patients completed 4 cycles treatment. Unfortunately, 2 of them were confirmed PD by imaging. In addition, two patients refused gastrectomy and withdrew from the study. Eventually, 45 patients underwent gastrectomy, of which 3 patients had intraperitoneal metastases during the operation. A total of 42 patients were evaluable, all of them gained R0 resection (100%), 4 patients (10%) achieved pCR and 10 patients (24%) reached TRG1. Among the patients experienced pCR, one of them was Her-2 positive, one was MSI-H, the rest two of them were PD-L1-positive (CPS≥10). The most common ≥grade 3 adverse events (AEs) were neutropenia (35%) and leukopenia (16%). Only 1 patient (2%) experienced grade 3 immune-related AEs of alanine aminotransferase and aspartate aminotransferase increase. No serious AEs resulted in termination of treatment or death. Conclusions: Camrelizumab combined with FOLFOX was an effective and safe neoadjuvant therapy strategy for patients with resectable locally advanced GC/GEJC. Furthermore, the analysis of biomarkers with clinical benefits is undergoing. Clinical trial information: NCT03939962. [Table: see text]

scholarly journals A Phase Ii Study Of The Combination Of Oxaliplatin, Capecitabine, And Trastuzumab And Chemo-radiotherapy In The Adjuvant Setting In Operated Patients With Her2+ Gastric Or Gastroesophageal Junction Cancer (Toxag Study), A Turkish Oncology Group Study

2020 ◽  
Author(s):  
Huseyin Abali ◽  
Suayib Yalcin ◽  
Huseyin Cem Onal ◽  
Faysal Dane ◽  
Berna Oksuzoglu ◽  
...  
Keyword(s):  
Overall Survival ◽  
Phase Ii ◽  
Gastroesophageal Junction ◽  
Disease Free Survival ◽  
R0 Resection ◽  
Her2 Overexpression ◽  
Her2 Positive ◽  
Open Label ◽  
Gastroesophageal Junction Cancer ◽  
Gastroesophageal Junction Adenocarcinoma

Abstract BackgroundTrastuzumab prolonged the overall survival in patients with advanced gastric cancer with HER2 overexpression in combination with chemotherapy. In this phase II open-label prospective study, the tolerability and safety of trastuzumab with chemotherapy, and chemoradiotherapy for curatively resected patients with HER2 + gastric carcinoma was investigated. MethodsThe patients with HER2-positive gastric, or gastroesophageal junction adenocarcinoma, after gastrectomy plus D2 dissection were included. They received 3 cycles of oxaliplatin (100 mg/m2 IV day 1) plus capecitabine (850 mg/m2 PO days 1-14), trastuzumab (8 mg/kg IV day 1 in cycle 1, 6 mg/kg thereafter) every 21 days, followed by chemoradiotherapy. Trastuzumab was given for 1 year.ResultsOf the 212 patients screened, 35 were eligible, and 34 were treated. The median age was 56 years (Min-max: 35-75), male patients constituted 73.5% (n=25), and 33 (97.1%) had gastric adenocarcinoma. R0 resection was performed in 30 (88.2%). The majority (26, 61.7%) were in stage III disease. Most of the AEs were grade I/II, the most frequent grade III side effects were nausea (3, 8.8%), vomiting (3, 8.8%), diarrhoea (2, 5.9%) and weight loss (N=2, 5.9%). Two patients died during the first 3 cycles of chemotherapy and chemoradiotherapy; 1 secondary to pulmonary thrombo-embolism, and the other due to cerebral ischemia. After excluding 2 with early progression and 1 consent withdrawal, of the remaining 31 patients, 28 (90.3%) were able to complete the chemotherapy and chemoradiotherapy part of the trial. After the 25 months follow up period, 21 patients (61.8%) were alive. Overall survival at 12 and 24 months was 75.0% and 65.7%, while disease-free survival at 12 and 24 months was 65.7% and 55.0%, respectively.ConclusionsTrastuzumab in combination with capecitabine, oxaliplatin and radiotherapy as the adjuvant therapy for gastric or gastroesophageal junction adenocarcinoma was considered safe and tolerable. The frequency of HER2 overexpression in curatively resected patients is comparable to that in patients with metastatic disease.

scholarly journals Efficacy of Neoadjuvant Chemotherapy DOX and XELOX Regimens for Patients with Resectable Gastric or Gastroesophageal Junction Adenocarcinoma

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Yuan Tian ◽  
Qun Zhao ◽  
Yong Li ◽  
Liqiao Fan ◽  
Zhidong Zhang ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Complete Response ◽  
Short Term ◽  
Aged Patients ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
Surgery Group ◽  
Common Grade ◽  
Grade 3

Purpose. This paper is aimed at comparing the short-term efficacy of the combination of docetaxel, oxaliplatin, and capecitabine (DOX) with the combination of oxaliplatin and capecitabine (XELOX) as neoadjuvant chemotherapy regimens for the treatment of patients with resectable gastric or gastroesophageal junction adenocarcinoma. Methods. A total of 300 patients aged 20-60 years with resectable gastric or gastroesophageal junction adenocarcinoma who were evaluated with cT3/4Nany were randomly assigned into 3 groups: DOX group ( n = 100 , treated with neoadjuvant DOX plus adjuvant XELOX), XELOX group ( n = 100 , treated with perioperative XELOX), and surgery group ( n = 100 , treated with adjuvant XELOX). Results. A total of 93, 92, and 95 patients were enrolled in the DOX, XELOX, and surgery groups, respectively. The pathological complete response (pCR) rate was 16.1% in the DOX group and 4.3% in the XELOX group ( P = 0.008 ). There were 56 (61.3%) patients in the DOX group who presented with surgical complications, 22 (23.9%) patients in the XELOX group, and 37 (38.9%) patients in the surgery group. The most common grade 3-4 adverse events in these three groups were neutropenia (32.3%, 30.4%, and 21.1%), leucopenia (21.5%, 22.8%, and 15.8%), nausea (15.1%, 16.3%, and 12.6%), and fatigue (10.8%, 7.6%, and 8.4%). Conclusions. Neoadjuvant DOX is an effective and feasible regimen and might represent an option for young and middle-aged patients with locally advanced, resectable gastric or gastroesophageal junction adenocarcinoma.

scholarly journals Multimodal management of gastroesophageal junction adenocarcinoma: Which type of neoadjuvant treatment?

2021 ◽  
Vol 108 (Supplement_4) ◽  
Author(s):  
E Zandirad ◽  
H Teixeira-Farinha ◽  
N Demartines ◽  
M Schäfer ◽  
S Mantziari
Keyword(s):  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Disease Free Survival ◽  
R0 Resection ◽  
Term Survival ◽  
Free Survival ◽  
Long Term Survival ◽  
Disease Free

Abstract Objective The current treatment for locally advanced gastroesophageal junction (GEJ) adenocarcinoma consists of neoadjuvant treatment (NAT) followed by surgery. Preoperative chemotherapy (CT) and radio-chemotherapy (RCT) are both valid options, but comparative data for their efficacy remain scarce. This study aimed to assess the efficacy of RCT and CT to achieve a complete pathologic response (CPR) for locally advanced GEJ adenocarcinoma. Secondary endpoints were R0 resection rates, postoperative complications, long-term survival and recurrence. Methods All consecutive patients with locally advanced GEJ adenocarcinoma treated with CT or RCT and oncologic resection from 2009 to 2018 were included. A CPR was defined with the Mandard tumor regression score. Standard statistical tests were used as appropriate. Overall and disease-free survival were compared with the Kaplan Meier method and log-rank test. Multivariate analysis was performed to define independent predictors of CPR, and long-term survival. Results Among the 94 patients (84%male, median age 62 years [IQR 9.7]), 67 (71.3%) received preoperative RCT and 27 (28.7%) CT. Patient’s characteristics and pretreatment tumor stages were comparable. Surgical approach was thoracoabdominal Lewis resection in 95.5% RCT and 81.5% CT patients (P = 0.085). CPR was more frequent in the RCT than the CT group (13.4% vs 7.4%, P = 0.009), but R0 resection rates were similar (72.1% vs 66.7%, P = 0.628). There was a trend to higher ypN0 stage in the RCT group (55.2% vs 33.3%; P = 0.057). Postoperatively, RCT patients presented more cardiovascular complications (35.8% vs 11.1%; P = 0.017), although overall morbidity was similar (68.6% vs 62.9%, P = 0.988). 5-year overall survival was comparable (61.1% RCT vs 75.7% CT, P = 0.259), as was 5-year disease-free survival (33.5% RCT vs 22.8% CT, P = 0.763). Isolated loco-regional recurrence occurred in 2.9% RCT vs 3.7% CT patients (P = 0.976). NAT type was not an independent predictor for complete pathologic response nor long-term survival in the multivariate analysis. Median follow-up was 30 months [95%CI 21.3-38.8] for all patients. Conclusion Patients with locally advanced GEJ adenocarcinoma demonstrated higher rates of CPR after RCT than CT, and a trend to a better lymph node sterilization, although this did not translate in a significant survival benefit or decreased recurrence rate.

Sign in / Sign up

Export Citation Format

Share Document