Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Smyth, Elizabeth; Verheij, Marcel; Allum, William; Cunningham, David; Cervantes, Andrés; Arnold, Dirk

doi:10.1093/annonc/mdw350

Cited by 1,331 publications

(1,378 citation statements)

References 102 publications

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“…Trastuzumab is an established treatment option for patients with HER2 + breast cancer [9,14,15,17] and HER2 + gastric and gastroesophageal junction cancer [19][20][21]. In clinical trials, trastuzumab is associated with increased pathological complete response rates and eventfree survival rates when used as part of a neoadjuvant treatment regimen in early HER2 + breast cancer [31][32][33], and increased rates of disease-free and overall survival rates when used as a component of adjuvant treatment [10,34,35].…”

Section: Discussionmentioning

confidence: 99%

“…The combination of reference trastuzumab with chemotherapy in HER2 + breast cancer has been shown to improve response rates, reduce recurrence risk and increase survival, compared with chemotherapy alone [9][10][11][12][13], findings that support the inclusion of this approach in European [9,14] and USA [15][16][17] treatment guidelines. Such combination therapy also increases survival, compared with chemotherapy alone, in advanced HER2 + gastric or gastroesophageal junction cancers [18], as reflected in clinical guidelines [19][20][21].…”

Section: Introductionmentioning

confidence: 99%

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A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab

Esteva¹,

Stebbing

Wood-Horrall³

et al. 2018

Cancer Chemother Pharmacol

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Purpose Access to trastuzumab, a valuable anti-cancer treatment, can be limited by cost. The primary aim of this study was to evaluate and compare the PK profiles of CT-P6, a biosimilar of trastuzumab, and US-licensed reference trastuzumab (Herceptin ® ) in healthy subjects. Secondary study aims included comparison of the safety and immunogenicity of CT-P6 and reference trastuzumab in these subjects. Methods We performed a single-dose, randomised, double-blind, parallel group study (NCT02665637) comparing CT-P6 with reference trastuzumab (6 mg/kg, 90 min intravenous infusion) in 70 healthy adult males. Pharmacokinetics, safety and immunogenicity were evaluated up to 10 weeks post-dose. Primary endpoints were area under the serum concentration-time curve (AUC) from time 0 to infinity (AUC inf ); AUC from time 0 to last quantifiable concentration (AUC last ); and observed maximum serum concentration (C max ). The pre-determined equivalence criterion was a 90% confidence interval of 80-125% for ratios of geometric least squares (LS) means. Results Equivalence of CT-P6 and reference trastuzumab was demonstrated. Ratios (CT-P6/reference trastuzumab) of geometric LS means (90% confidence interval) were: AUC inf 99.05 (93.00, 105.51); AUC last 99.30 (92.85, 106.20); C max 96.58 (90.93, 102.59). Safety profiles were similar; treatment-emergent adverse events occurred in ten subjects (28.6%) in the CT-P6 group and 11 (31.4%) in the reference trastuzumab group. No serious adverse events or deaths occurred. No subjects tested positive for anti-drug antibodies. Conclusions These data add to the totality of evidence required to demonstrate biosimilarity. A phase III study of CT-P6-in which equivalent neoadjuvant efficacy to reference trastuzumab has been demonstrated-is ongoing.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab

Esteva¹,

Stebbing

Wood-Horrall³

et al. 2018

Cancer Chemother Pharmacol

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“…As a well-accepted oral fluoropyrimidine drug internationally, capecitabine-containing regimens such as XELOX have become the recommended standard adjuvant treatment following radical gastrectomy for AGC patients in many western and east-Asian countries [5,9,10], mainly based on the survival benefit reported in the CLASSIC trial [8] in stage II-IIIB GC patients who received XELOX following D2 dissection. Capecitabine-based adjuvant regimens (especially XELOX) have also been commonly used in China, but the optimal regimen and the clinical decisionmaking steps cannot easily be duplicated from other countries because GC in China has unique characteristics, including later-stage disease, larger tumor sizes and a higher incidence of positive lymph nodes in comparison with western communities [4], and the disease status in the majority of patients differs from that in other eastAsian countries (advanced-stage disease in China vs early stage disease in Japan and Korea) [7].…”

Section: Discussionmentioning

confidence: 99%

A Review of Capecitabine-Based Adjuvant Therapy for Gastric Cancer in the Chinese Population

Cheng

2017

Future Oncol.

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In China, the treatment of locally advanced gastric cancer (AGC) faces unique challenges. Chinese patients may harbor more unfavorable prognostic factors than western populations and, in comparison with other Asian populations such as Japan and South Korea, a higher proportion of Chinese patients are diagnosed with AGC due to inadequate early diagnosis of the malignancy. This review summarizes the use of combination chemotherapy regimens with capecitabine as adjuvant therapy in the Chinese AGC population. Based on the available domestic data in China, the review concludes that capecitabine-based chemotherapy regimens, especially XELOX, offer good efficacy following radical gastrectomy in patients with AGC, with a low incidence of adverse events, acceptable tolerance, greater patient convenience and a lower overall cost than other regimens.

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“…Relevance of prophylactic lymph node dissection has been discussed thoroughly elsewhere,7, 8 and various guidelines currently support standard application of D2 dissection to treat resectable advanced gastric cancer 2, 9. However, cancer can spread beyond the boundary of standard D2 dissection.…”

Section: Lymph Node Metastasismentioning

confidence: 99%

Surgery with curative intent for stage IV gastric cancer: Is it a reality of illusion?

Kodera

2018

Annals of Gastroent Surgery

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Gastric cancer with metastases outside of the regional lymph nodes is deemed oncologically unresectable. Nevertheless, some metastatic lesions are technically resectable by applying established surgical techniques such as para‐aortic lymphadenectomy and hepatectomy. At the time of compilation of the Japanese gastric cancer treatment guidelines version 4, systematic reviews were conducted to see whether it is feasible to make any recommendation to dissect both the primary and metastatic lesions with intent to cure, possibly as part of multimodality treatment. Long‐term survivors were found among carefully selected groups of patients both in prospective and retrospective studies. In addition, there is a growing list of publications reporting encouraging outcomes of gastrectomy conducted after exceptionally good response to chemotherapy, usually among patients who underwent R0 resection. This type of surgery is often referred to as conversion surgery. It is sometimes difficult to define a clear borderline between curative surgery scheduled after neoadjuvant chemotherapy and the conversion surgery. This review summarizes what we knew after the literature reviews conducted at the time of compiling the Japanese guidelines and in addition reflects some new findings obtained thereafter through clinical trials and retrospective studies. Metastases were divided into three categories based on the major metastatic pathways: lymphatic, hematogenous, and peritoneal. In each of these categories, there were findings that could provide hope for patients with metastatic disease. These findings implied that the surgical technique that we already use could become more useful upon further developments in antineoplastic agents and drug delivery.

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Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Cited by 1,331 publications

References 102 publications

A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab

A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab

A Review of Capecitabine-Based Adjuvant Therapy for Gastric Cancer in the Chinese Population

Surgery with curative intent for stage IV gastric cancer: Is it a reality of illusion?

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