Phase II trial of preoperative chemoradiation plus perioperative SOX chemotherapy in patients with locally advanced gastric cancer

Liu, Xiaowen; Li, Guichao; Long, Ziwen; Yin, Jun; Zhu, Xiaoyan; Sheng, Weiqi; Huang, Dan; Zhu, Hui; Zhang, Zhaozhen; Cai, Hong; Huang, Hua; Zhao, Guijuan; Zhou, Ye; Zhang, Zhen; Wang, Yanong

doi:10.1002/jso.24917

Cited by 16 publications

(21 citation statements)

References 23 publications

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“…This improvement may be attributed to the addition of apatinib to chemotherapy. The pathologic CR rate was 13.8%, which is higher than the 8% and 8.5% observed in another Chinese trial and a Japanese trial with neoadjuvant SOX [32,33], and similar to the 11% observed in the ST03 trial with epirubicin, cisplatin, capecitabine and bevacizumab [34], the 16% observed in the FLOT-4 trial with current standard therapy of docetaxel, oxaliplatin, leucovorin and fluorouracil [35] and the 13.9% observed in a phase II Chinese trial with preoperative chemoradiation and neoadjuvant SOX [36]. The relatively high preoperative ORR of 79.3% was higher than previous reports [7,33,34,36].…”

Section: Variablementioning

confidence: 49%

Effect of apatinib plus neoadjuvant chemotherapy followed by resection on pathologic response in patients with locally advanced gastric adenocarcinoma: A single-arm, open-label, phase II trial

Zheng

Yang

Yan

et al. 2020

European Journal of Cancer

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Background: The evidence of combining neoadjuvant chemotherapy with targeted therapy for patients with locally advanced gastric cancer is inadequate. We conducted a singlearm phase II trial to evaluate the efficacy and safety of S-1, oxaliplatin and apatinib (SOXA) in patients with locally advanced gastric adenocarcinoma. Methods: Treatment-naïve patients received three preoperative cycles of S-1 (80e120 mg/day on days 1e14) and oxaliplatin (130 mg/m 2 on day 1) and two cycles of apatinib (500 mg/day for 21 days) at 3-week intervals, followed by surgery. The primary end-point was pathologic response rate (pRR). This trial is registered at ChiCTR.gov.cn: ChiCTR-OPC-16010061. Results: Of 29 patients included, median age was 60 (range, 43e73) years; 20 (69.0%) were male. The pRR was 89.7% (95% confidence interval [CI], 72.7%e97.8%; 26 of 29 patients; P < 0.001) with 28 patients treated with surgery. All 29 patients were available for preoperative response evaluation, achieving an objective response rate of 79.3% (95% CI, 60.3% e92.0%) and a disease control rate of 96.6% (95% CI, 82.2%e99.9%). The margin-free resection rate was 96.6% (95% CI, 82.2%e99.9%). The pathologic complete response rate was 13.8% (95%CI, 1.2%e26.3%). Downstaging of overall TNM stage was observed in 16

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Section: Variablementioning

confidence: 49%

Effect of apatinib plus neoadjuvant chemotherapy followed by resection on pathologic response in patients with locally advanced gastric adenocarcinoma: A single-arm, open-label, phase II trial

Zheng

Yang

Yan

et al. 2020

European Journal of Cancer

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“…For example, phase II clinical studies have shown that neoadjuvant concurrent radiotherapy and chemotherapy (SOX scheme) can treat locally advanced gastric cancer; one study showed that in 24 patients (67%) who received radical surgery, the PCR rate was 13.9%, and the median survival time was 30.3 months. 16 Preoperative chemoradiation may be an effective treatment strategy among patients with locally advanced gastric adenocarcinoma, However, it still needs to be confirmed by a large sample study. In addition, the value of neoadjuvant radiotherapy and chemotherapy in patients with HER-2-positive advanced gastric cancer is not clear, especially if the combination of trastuzumab treatment increases the cardiotoxicity, so this study only uses the neoadjuvant treatment mode based on trastuzumab.…”

Section: Discussionmentioning

confidence: 99%

“…5 A stage III ToGA clinical study showed that the efficacy of trastuzumab combined with an XP/FP regimen in patients with HER-2-positive advanced esophagogastric junction or gastric cancer was significantly better than that of patients receiving only chemotherapy. Median OS was 13.8 months (95% confidence interval [CI] [12][13][14][15][16] for patients assigned to the trastuzumab plus chemotherapy arm compared with 11.1 months (95% CI [10][11][12][13] in the chemotherapy group (hazard ratio [HR] 0.74; 95% CI 0.60--0.91; p = 0.0046). Especially in the patients with HER-2 immunohistochemistry 2 + and FISH positive or the patients with HER-2 immunohistochemistry 3 +, the survival improvement was more obvious, with the median OS better in the experimental arm (16.8 vs 11.8 months, HR: 0.65).…”

Section: Introductionmentioning

confidence: 99%

<p>Trastuzumab with FLOT Regimen for the Perioperative Treatment of Resectable HER2 + Advanced Gastric Cancer: A Retrospective Study</p>

Tong¹,

Li²,

Lin³

et al. 2020

CMAR

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These authors contributed equally to this workBackground: The aim of this study was to evaluate the efficacy and safety of trastuzumab, combined with the FLOT regimen, in the perioperative treatment of resectable HER-2-positive advanced gastric cancer. Methods: Overall, 45 patients were divided into two groups; 29 patients in the experimental group were treated with trastuzumab combined with FLOT and 16 patients in the control group were treated with FLOT alone. The primary endpoint was objective response rate (ORR), and the secondary endpoints were disease control rate (DCR), tumor regression grade (TRG), surgical margin, side effects, and overall survival. Results: In the experimental and control groups, ORR was 72.4% and 43.8% (p=0.226), DCR was 89.7% and 87.5%, R0 resection rate was 96.5% and 93.7%, total/subtotal tumor regression grade was 17.2% and 6.3%, partial tumor regression grade was 27.6% and 18.7% (p=0.468), and 2-year survival rate was 78.1% and 73.9% (p=0.932), respectively. The common side effects were agranulocytosis and vomiting. There was no significant difference between the two groups. Conclusion: Trastuzumab combined with FLOT has a good curative effect and safety profile in the perioperative treatment of patients with resectable HER-2-positive advanced gastric cancer. In addition, trastuzumab + FLOT had the same result as FLOT alone, as there was no significant benefit with the addition of T in the group studied.

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“…Nevertheless, this drug is not available in Western countries. In some recent studies, S-1 was administered concomitantly to RT, alone[ 48 - 50 ] or in combination with cisplatin, both in a preoperative and postoperative setting[ 51 , 52 ]. No excessive toxicities and encouraging outcomes were reported, and an MTD ranging between 70 and 80 mg/m 2 was identified.…”

Section: Recent Evidence Of Novel Chemotherapeutic Regimens and Modermentioning

confidence: 99%

Between evidence and new perspectives on the current state of the multimodal approach to gastric cancer: Is there still a role for radiation therapy?

Agolli

Nicosia

2018

WJGO

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In patients affected by gastric cancer (GC), especially those in advanced stage, the multidisciplinary approach of treatment is fundamental to obtain a good disease control and quality of life. Although many chemotherapeutics in combination to radiotherapy are adopted in the peri- or postoperative setting, the most optimal timing, regimens and doses remains controversial. In the era of radical surgery performed with D2-lymphadenectomy, the role of radiation therapy remains to be better defined. Categories of patients, who could benefit more from an intensified local treatment rather than more toxic systemic therapy, are still under investigation. Evidence and recent updates of the randomized trials, meta-analysis and prospective trials show that the postoperative radiotherapy plays a fundamental role in reducing the loco-regional recurrence and in turn the disease-free survival in operable advanced GC patients, also after a well performed D2 surgery. Therapeutic decisions should be taken considering the individual patients, but the multimodal approach is necessary to guarantee a longer survival and a good quality of life. Ongoing randomized trials could better define the timing and the combination of radiotherapy and systemic therapy.

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Phase II trial of preoperative chemoradiation plus perioperative SOX chemotherapy in patients with locally advanced gastric cancer

Abstract: Preoperative chemoradiation may be an effective treatment strategy among patients with locally advanced gastric adenocarcinoma.

Cited by 16 publications

References 23 publications

Effect of apatinib plus neoadjuvant chemotherapy followed by resection on pathologic response in patients with locally advanced gastric adenocarcinoma: A single-arm, open-label, phase II trial

Effect of apatinib plus neoadjuvant chemotherapy followed by resection on pathologic response in patients with locally advanced gastric adenocarcinoma: A single-arm, open-label, phase II trial

<p>Trastuzumab with FLOT Regimen for the Perioperative Treatment of Resectable HER2 + Advanced Gastric Cancer: A Retrospective Study</p>

Between evidence and new perspectives on the current state of the multimodal approach to gastric cancer: Is there still a role for radiation therapy?

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