Standard Treatment Guidelines 5th Edition Pdf Free Download ((LINK))

To compile this version, the guideline committee nominated several working groups, each assigned to make relevant contributions to unsolved issues on the following topics: (1) surgery and lymphadenectomy for junctional cancer, (2) clinical pathway, (3) follow-up after curative surgery, (4) treatment of technically resectable metastatic cancer, (5) risk calculation for surgical intervention and (6) treatment of cancer of the gastric remnant. Of these, tentative consensuses were reached on the first three topics that were included as new sections in the text, whereas further discussion was deemed necessary for the last two topics. The clinical importance of the fourth topic and lack of hard evidence related to that topic prompted the committee to establish a Q and A section to provide tentative best answers to important clinical questions on technically resectable metastatic cancer.

Regarding total gastrectomy by this approach, no prospective trial has been reported. Thus, laparoscopic total gastrectomy has been rated by the guidelines of the Japan Society for Endoscopic Surgery (2014) as recommendation C1 (may be considered for a patient in need of total gastrectomy, but no scientific evidence in support of the procedure is currently available). Those who consider challenging the procedure should plan to do so with sufficient caution since postoperative complications were reported to be significantly more frequent in the first year of its introduction.

Standard Treatment Guidelines 5th Edition Pdf Free Download

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As the evidence is still insufficient for differentiated type tumors accompanied with some areas of undifferentiated type histology, the following resections are regarded as non-curative for the time being, and addition of surgical treatments should be recommended.

Regimens included in this category will need to be either superior or non-inferior to the standard treatment in a phase III trial with overall survival as the primary endpoint. In addition, consensus must be reached within the committee members on the interpretation of the phase III study results, availability of the drugs in Japan and sufficient safety and efficacy data with the Japanese participants.

Regimens in this category include the following: (1) those that were found to be superior or non-inferior to the standard treatment in a phase III trial but failed to gain sufficient support from the committee members to be included in category 1; (2) those with sufficient efficacy and safety data obtained in a phase II trial and consensus reached among the committee members.

Capecitabine + cisplatin combination is currently one of standard treatments overseas and was employed as a control group in global phase III studies, the ToGA trial [17] and AVAGAST trial [18]. Since subset analyses of the Japanese participants in these trials have shown safety and efficacy, this combination can be selected in clinical practice (recommendation category 2).

Regarding triplet regimens, efficacy of infusional 5FU + cisplatin + docetaxel was proven in the V325 study [21] conducted in the western countries. Given the excessive toxicity and lack of data for Japanese patients, this regimen cannot be recommended for general practice (recommendation category 3). In Japan, a triplet consisting of S-1, cisplatin and docetaxel (DCS regimen) is currently being evaluated in a phase III trial, JCOG1013, following some phase II results. Thus, the DCS regimen currently needs to be regarded as an investigational treatment.

Randomized trials conducted in Germany [24] and Korea [25] showed a significant survival advantage of the second-line treatment (docetaxel or irinotecan) over the best supportive care. A Japanese phase III trial, WJOG4007 [26], failed to prove superiority in overall survival of irinotecan over paclitaxel (weekly administration), but did show median survival time for both groups of approximately 9 months, which is favorable when compared with survival data from other trials exploring the second-line chemotherapy. This could be explained by the fact that a high proportion of participants in this trial received another line of treatment (taxanes among patients allocated to the irinotecan group and irinotecan among those allocated to the paclitaxel group). Thus, this trial indicates that patients with good performance status could benefit from the third-line treatments.

Answer Multidisciplinary treatment including standard gastrectomy can be proposed for patients with no other non-curative factors. If the CY1 status was revealed after surgery, postoperative treatment with S-1 can be recommended as the tentative standard.

More recently, a prospective phase II study was conducted in which technically resectable cancer with CY1 as the only non-curative factor (patients with minimal and resectable peritoneal deposits included) was treated by standard gastrectomy followed by S-1 monotherapy until disease progression. The median recurrence-free and overall survival time in this study were 376 and 705 days, and 5-year recurrence-free and overall survival rates were 21 and 26 %, respectively [45]. In addition, a single-institution retrospective study of 120 CY1 patients who underwent surgery followed by S-1 monotherapy revealed a 5-year survival rate of 26.6 % [46], which was compatible with the trial result. These results are far better than the results obtained before S-1 became available and are equivalent to that of a series of curatively resected linitis plastica-type cancers, which often recur as peritoneal disease [47]. Furthermore, CY1 patients are deemed eligible for JCOG0501, a phase III trial to explore neoadjuvant chemotherapy by S-1 + cisplatin for scirrhous type gastric cancer in which the standard treatment arm consists of standard gastrectomy followed by S-1.

These facts indicate that CY1 patients could be indicated for the strategy consisting of standard gastrectomy and perioperative chemotherapy. In addition, S-1 monotherapy could be recommended for patients whose CY1 status was informed after gastrectomy. On the other hand, if the information on CY status was available prior to surgery, a chemotherapy-first strategy could be taken whereby only patients whose cytology status turned negative could be indicated for surgery [48, 49]. However, details of the optimal multidisciplinary treatment strategy in this setting, including the chemotherapeutic regimen to be used and the number of cycles to be delivered, remain to be elucidated in future clinical trials.

Postoperative adjuvant chemotherapy with S-1 has been established as a standard of care for p-Stage II/III gastric cancer by the ACTS-GC trial. However, the treatment for patients who had recurrent disease after the adjuvant treatment remains to be elucidated.

The response rate of treatment by S-1 + cisplatin is reportedly low (5 %) for patients who had recurrence within 6 months from completion of the S-1 adjuvant therapy when compared with the response rate for recurrences after 6 months from the completion (37.5 %) [50]. This result, found in a multi-institutional retrospective analysis, suggests that cancers that recur during or early after completion of an adjuvant chemotherapy are resistant to the drug used in that chemotherapy. On the other hand, a retrospective analysis of the patients registered for the ACTS-GC study revealed that patients who received S-1 among other drugs in salvage line treatments survived longer after recurrence than those who did not receive S-1, regardless of the time interval between the adjuvant chemotherapy and recurrence. However, results of this study will have to be interpreted with caution since the study suffers from several biases in the background of the patients such as whether oral food intake was possible (patients who did not receive S-1 after recurrence might have been those with bowel obstruction who were unable to eat and suffered from poor performance status).

In treatment for colorectal cancer during the era of adjuvant chemotherapy with 5FU alone, drugs used in the salvage line treatment depended on the time interval between the completion of the adjuvant chemotherapy and recurrence. New regimens have been developed as first-line therapy for patients who had recurrence more than 6 months after completion of the adjuvant treatment and as second line for those who had recurrence during or within 6 months of the adjuvant therapy.

The same rule has been applied for gastric cancer, and patients with late recurrence after adjuvant treatment have been deemed eligible for clinical trials exploring a first-line treatment, whereas those with early recurrences were registered in clinical trials for the second-line treatment.

Thus, patients with recurrences during or early after completion of the adjuvant treatment are considered as targets of second-line treatments, and S-1 monotherapy is usually avoided for this population. However, there is currently no evidence to recommend any specific regimen for this setting.

In a phase II trial exploring weekly administration of paclitaxel in gastric cancer patients with ascites, improvement in the volume of ascites evaluated by a five-point measurement using the CT image was seen in 39 % (25/64) of the patients [53]. In a randomized phase II trial comparing second-line treatment by weekly administration of paclitaxel with the best available 5FU (either 5FUci or MTX + 5FU, which was not used in the first-line treatment) in patients with peritoneal metastases, a benefit in progression-free survival was proven, but no difference was detected in overall survival. However, paclitaxel was associated with a more favorable toxicity profile [54]. These results indicate that weekly paclitaxel can be considered for patients with severe peritoneal disease in both the first- and second-line setting. In addition, a phase II trial of the FLTAX regimen, which is a combination of paclitaxel with 5FU + LV, has shown that this combination reduced ascites in 44 % of patients [55]. Further evidence through a randomized comparison of the combination with a single-agent treatment is awaited. 17dc91bb1f