2015-02-06 16:32
Source: Ding Xiang Garden Author: Tang Ligong, Department of General Surgery, Henan Cancer Hospital, China
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The 3rd edition of the Japanese Guidelines for the Treatment of Gastric Cancer (hereinafter referred to as “the Guidelines”) was published in 2010, which has had a great impact on the surgical treatment of gastric cancer and has led to more standardization, rationalization and standardization of gastric cancer treatment. In recent years, new scientific findings have led to two revisions and reissues of the Guidelines, and the 4th edition of the Guidelines in 2014 revised seven major issues and introduced new evidence and criteria (updating the definition of gastric surgery. The provisional rules and flowchart for lymph node dissection in cases of esophagogastric union cancer <4 cm; establishment of laparoscopic distal gastrectomy as routine treatment for stage I gastric cancer; criteria for gastroscopic treatment; recommendations for chemotherapy regimens; recommendations and flowchart for HER2-negative and positive gastric cancer; and rules for surgery and chemotherapy and postoperative follow-up for M1 gastric cancer). The 4th edition of the "Guidelines" draws on the latest scientific achievements, and provides important guidance for future clinical practice by making the basic principles and concepts of gastric cancer treatment more scientific and precise.
In October 2010, the 3rd edition of the Japanese “Guidelines for the Treatment of Gastric Cancer” (hereinafter referred to as “the Guidelines”) was released, which greatly changed the basic concept of gastric cancer treatment, and the new treatment principles based on high-level evidence-based medicine have brought gastric cancer treatment into a new era. In recent years, new research results have emerged, and it is urgent to supplement and update the “Guidelines”.
In May 2014, the Japanese Society of Gastric Cancer revised the 3rd edition of the Guidelines and issued the 4th edition of the Guidelines, which clarifies and scientifically clarifies the basic principles and concepts of gastric cancer treatment. The new treatment guidelines have been established and provide important guidance for future clinical treatment.
The main points of this revision and update are
(1) Updating the definition of gastric surgery methods.
(2) Formulation of provisional rules and flow chart for lymph node dissection in esophagogastric union cancer <4cm in length.
(3) Determining that laparoscopic distal gastrectomy for stage I gastric cancer can be a routine treatment.
(4) Regarding gastroscopic treatment, it is stipulated that differentiated carcinoma with undifferentiated components, <3 cm in diameter, UL(+), and pT1a are suitable for extended curative resection. In addition, the treatment of histological muc and the diagnostic criteria of UL were added.
(5) The recommended level of chemotherapy regimens was set, and the recommended regimens for HER2-negative and positive gastric cancers were documented and flowcharted.
(6) Seven clinical questions are set, answered and explained for treatment guidelines when M1 gastric cancer can be resected and for chemotherapy when standard chemotherapy regimens are difficult to apply.
(7) A template was created regarding postoperative clinical pathways and follow-up for gastric cancer.
The main contents of this update are described below.
1 Update of the definition of gastric cancer surgery
The types of surgery remain the same: total gastrectomy, distal gastrectomy, pylorus-preserving gastrectomy, proximal gastrectomy, segmental gastrectomy, partial gastrectomy, and non-excisional surgery. However, each type of surgery is clearly defined.
(1) Total gastrectomy (TG) Total gastrectomy with the cardia (esophagogastric junction) and pylorus (pyloric wheel).
(2) Distal gastrectomy (DG) Gastrectomy with the pylorus, preserving the cardia, standard procedure is to remove more than 2/3 of the stomach.
(3) pylorus-preserving gastrectomy (PPG) Gastrectomy with preservation of the upper third of the stomach and the pylorus and part of the pyloric antrum.
(4) Proximal gastrectomy (PG) Gastrectomy with the cardia (esophagogastric junction), preserving the pylorus.
(5) Segmental gastrectomy (SG) total circumferential resection of the stomach with preservation of the cardia and pylorus, except for those who are suitable for pylorus preservation gastrectomy.
(6) Local resection (LR) non-perimeter resection of the stomach.
(7) Non-excisional surgery (anastomosis, gastric fistula and enterostomy).
For post-operative residual gastric cancer, the surgical procedures are as follows: (8) total gastrectomy (completion gastrectomy) initial surgical procedure not counting, total gastrectomy of the residual stomach including cardia or pylorus.
(9) Subtotal resection of remnant stomach (subtotal resection of remnant stomach) is a distal gastrectomy with preservation of the cardia.
2 Provisional rules and flow chart of lymph node dissection for esophagogastric union cancer <4cm in length
The Japanese Society of Gastric Cancer and the Japanese Society of Esophagology conducted a national survey in 2012 and 2013 on lymph node metastasis in esophagogastric union cancers less than 4 cm in length, and collected data from 3177 cases in 273 units. In this survey, we reviewed the surgical cases from 2001 to 2010 and developed a flow chart for lymph node dissection for esophagogastric union cancer under 4 cm in length based on the histological findings of the resected specimens with the depth of tumor infiltration, and tentatively set the benchmarks for lymph node dissection (Figure 1).
3 Laparoscopic gastrectomy
Laparoscopic gastrectomy was classified as an investigational procedure in the 3rd edition of the Guidelines because of the lack of definitive evidence of safety and long-term prognosis. This edition specifies laparoscopic surgery as an option for routine treatment of stage Ic cases that are suitable for distal gastrectomy.
The “Guidelines” of the Japanese Society of Endoscopic Surgery (2014 edition) recommend laparoscopic distal gastrectomy (recommendation B) for stage Ic gastric cancer in the “Statute for the Management of Gastric Cancer “14 and the superiority of short-term postoperative results, small prospective trials and analysis show that the phase II trial (JCOG0703) by skilled surgeons is safe, but more postoperative complications have been reported with less experience, and each unit should set benchmarks according to proficiency.
Regarding long-term outcomes, large-scale prospective studies on survival and quality of life in Japan and Korea (JCOG0912, K2ASS01) are underway, pending their results. A prospective clinical study (JLSSG0901) on the safety and long-term outcome of progressive gastric cancer is underway. Currently, there is no basis for a recommendation for laparoscopic distal gastrectomy for gastric cancer of stage IIc or higher.
There is no prospective study of laparoscopic total gastrectomy for early gastric cancer, and the Japanese Society of Endoscopic Surgery “Guidelines” (2014 edition) recommends degree C1 (can be done, but without adequate scientific basis). The procedure should be performed with caution because of the high rate of postoperative complications in the first year. Patients undergoing laparoscopic surgery should be adequately informed because of the uncertainty of long-term results.
4 About gastroscopic treatment
(1) In the histological classification of the Statute for the Management of Gastric Cancer14 edition, pap, tub1, and tub2 of the general type of malignancy are differentiated carcinoma, and por1, por2, and sig are undifferentiated carcinoma. SM When muc is present at the site of cancer infiltration, either differentiated carcinoma or undifferentiated carcinoma comes from, it is treated as non-curative resection.
(2) UL (ulcer) is determined by treating the ulcer seen histologically as UL (+), but it is sometimes difficult to determine the pathology of UL, and the preoperative biopsy scar is sometimes treated as ulcer scar. Therefore, the clinician should make a final judgment on the treatment approach based on imaging findings such as endoscopy and radiology, and the presence or absence of preoperative biopsy. Usually biopsy scar can capture a small area of limited fibrosis under the mucosal muscle plate, and when the two cannot be distinguished as UL(+) is determined.
(3) Specify differentiated carcinoma containing undifferentiated components, under 3 cm, UL (+), and pT1a suitable for extended curative resection.
5 Set the recommended degree of chemotherapy regimen (recommended regimen and flow chart for HER2-negative and positive gastric cancer)
5.1 Recommendations for chemotherapy regimens (divided into 3 categories)
Recommendation 1: Among the regimens with superiority or non-inferiority in phase III clinical trials targeting overall survival time, those with sufficient domestic data are recommended as category 1.
Recommendation 2: A protocol with proven superiority or non-inferiority in phase III clinical trials, but no consensus as a category 1 recommendation, or a protocol with proven effectiveness in phase II clinical trials.
Recommendation level 3: A protocol for which superiority, or non-inferiority, has not been demonstrated in the Phase III clinical trial primary evaluation program, or which has not demonstrated clinical effectiveness and sufficient evidence of safety data in Japan.
5.2 Recommended regimen for HER2-negative and positive gastric cancer
For HER2-positive gastric cancer, trastuzumab-containing chemotherapy is the standard of care. It is recommended that HER2 screening should be performed prior to primary chemotherapy.
5.2.1 HER2-negative gastric cancer
The S-1+ cisplatin regimen is recommended based on the results of the Japanese phase III SPIRITS trial and the JCOG9912 trial. Recommendation 1.
Capecitabine + cisplatin therapy is one of the standard therapies overseas and is also a control for the ToGA and AVAGAST trials, and the substratum analysis of the two trials in Japan also showed safety and efficacy, so it is an option. Recommendation 2.
S-1+ docetaxel did not show a significant difference in survival time compared to S-1 alone in the primary analysis of the START trial, but additional analysis showed prolonged survival time. This is an option for limited populations such as outpatients. Recommendation 2.
Irinotecan + cisplatin and irinotecan + S-1 therapy, both of which did not demonstrate prolonged survival compared with S-1 therapy alone. Not recommended as primary chemotherapy. Recommendation 3.
Regarding 3-drug combination therapy, the V325 trial of docetaxel + cisplatin + 5FU in Europe and the United States was effective. However, there is little experience with the balance of efficacy and toxicity in China, so clinical recommendations are not made. Recommendation 3.
The results of the phase II trial of docetaxel + cisplatin + S-1 (DOS) therapy were received in China, and the JCOG1013 trial is now underway, with DOS being the clinical trial phase at this stage.
5.2.2 HER2-positive gastric cancer
HER2-positive gastric cancer is defined as IHC3+ or FISH-positive study subjects in the ToGA trial, with prolonged survival in the substrate-analysis IHC3+ , or IHC2+ and FISH-positive HER2 high-detection group. Therefore, trastuzumab-containing chemotherapy is recommended for IHC3+, or IHC2+ and FISH-positive cases. Capecitabine (or 5-FU) + cisplatin + trastuzumab therapy is recommended. Recommendation 1.
The 3-week schedule of S-1 + cisplatin + trastuzumab therapy is an option based on the results of the phase II trial. However, there is insufficient data on efficacy and safety, recommendation 2.
5.2.3 The flow chart of chemotherapy for unresectable progressive gastric cancer and recurrent cancer is shown in Figure 2.
6 Treatment guidelines for gastric cancer with M1 lesions that can be resected and chemotherapy issues when standard chemotherapy regimens are difficult to apply
Question 1: If there is metastasis in the lymph nodes around the abdominal aorta in gastric cancer, is it not an indication for gastrectomy?
Answer: If there are a few lymph nodes enlargement limited to No.16a2, b1, and there are no other non-curative factors, a combination therapy including surgical resection with extended debulking can be applied selectively.
Question 2: What is the treatment policy for liver metastasis of gastric cancer?
Answer: If the number of metastases is small and there are no other non-curative factors, comprehensive treatment including surgical resection can be applied.
Question 3: What is the treatment policy for gastric cancer with positive intraperitoneal washout cytology (CY1)? What is the recommended chemotherapy regimen for CY1 cases where the primary site can be resected?
Answer: In the absence of other non-curative factors, a combination of treatment including standard surgery can be used. S-1 monotherapy is recommended when the primary site has been resected.
Question 4: What is the recommended chemotherapy regimen for recurrent cases during or early after the completion of postoperative adjuvant chemotherapy (within 6 months)?
A: There is no definite regimen, but most regimens other than S-1 monotherapy are chosen for routine secondary treatment of recurrence within 6 months.
Q5: What is the recommended treatment for patients with high peritoneal metastases who are unable to consume food orally or with large amounts of ascites?
A: The indication for chemotherapy is carefully determined by the systemic status. 5-FU and paclitaxel, which are less toxic, can be chosen.
Question 6: What is the recommended chemotherapy regimen for the elderly with unresectable tumor or recurrent gastric cancer?
Answer: S-1+ cisplatin is recommended for those with good systemic status, but full attention should be paid to side effects. S-1 single agent therapy can also be used depending on the situation.
Question 7: What is the recommended chemotherapy regimen for HER2 positive gastric cancer?
Answer: The recommended regimen is paclitaxel-based anticancer agents or irinotecan. Second chemotherapy with paclitaxel and trastuzumab may be effective for those who have not used trastuzumab before.
7 Clinical pathway and follow-up template after gastric cancer surgery
7.1 Addition of basic pathway additions
The basic pathways are shown in Table 1 for sharing between total gastrectomy, distal gastrectomy, and proximal gastrectomy, as well as open and laparoscopic surgery. Those with combined severe circulatory and respiratory complications, as well as liver disorders and renal dysfunction are excluded.
7.2 Post-operative follow-up for gastric cancer
The template for postoperative follow-up of gastric cancer is shown in Tables 2 and 3.
The above are the main contents updated and added to the 4th edition of the Japanese Guidelines for the Treatment of Gastric Cancer in 2014. The basic principles of gastric cancer treatment are still in accordance with the basic provisions of the 3rd edition of the Guidelines in 2010.
This article is extracted from the Chinese Journal of Practical Surgery, Vol. 35, No. 1, January 2015