Search

The status and prognostic value of the disagreement between physician and patient assessments of symptomatic adverse events (AEs) remain unclear for patients with metastatic colorectal cancer treated with first‐line cetuximab plus chemotherapy. Paired data on patient‐reported outcomes using the EORTC QLQ‐C30 and physician‐reported outcomes using the NCI‐CTCAE for eight symptomatic AEs (fatigue, pain, insomnia, dyspnea, constipation, appetite loss, nausea/vomiting, and diarrhea) were collected from a prospective trial assessing the relationships between treatment efficacy, AEs, and quality of life. The overall agreement rates between patient and physician reporting at 4 weeks ranged from 40.2% to 76.5% for 129 patients. The level of agreement based on Cohen's κ statistics was slight to poor for dyspnea, pain, fatigue, and insomnia, while it was moderate to fair for the remaining AEs. No clinicopathological characteristics of disagreement were found. The underreporting by physicians ranged from 12.5% (nausea/vomiting) to 56.7% (fatigue). The 2‐year overall survival (OS) rate was more favorable for patients with high agreement than for those with low agreement (71.2% vs. 46.5%, p = .016), and the agreement status was an independent factor of OS (HR, 2.31; 95% CI, 1.13–4.71; p = .022). For patients who were reported as asymptomatic by the physician, the presence of patient‐reported symptoms resulted in a trend toward poor prognostic outcomes for appetite loss, dyspnea, diarrhea, and constipation. These findings provide the clinical importance of the monitoring of patient‐reported symptoms that can be complementary to physician‐reported data to ensure more accurate clinical outcomes., The routine use of PROs could be complementary to physician‐reported outcomes to ensure the accurate assessment of symptomatic AEs and facilitate patient‐centered healthcare in clinical practice.

Background It remains unclear whether patients’ self‐perceptions of symptoms at baseline clinically impact the prognostic relevance, treatment efficacy, or toxicity profiles in metastatic colorectal cancer (mCRC) patients treated with the first‐line cetuximab and standard chemotherapy. Methods The data were collected from a prospective trial that assessed the relationships between quality of life (QOL), treatment efficacy, and adverse events (AEs). Results The analysis of 137 mCRC patients revealed a significant association between the presence of baseline tumor‐related symptoms and a lower overall survival (OS) compared to the absence of symptoms (HR, 2.49; 95% CI, 1.37‐4.62; P = .003). The asymptomatic responders had favorable outcomes compared to the symptomatic nonresponders (2‐year OS rates: 83.6% and 35.9%, respectively), while the symptomatic responders had similar outcomes to the asymptomatic nonresponders. The median postprogression survival differed significantly: 10.2 months for the symptomatic patients and 15.9 months for the asymptomatic patients (HR, 2.29; 95% CI, 1.25‐4.29, P = .008). The objective response rates and patient toxicity profiles were similar irrespective of the severity of baseline symptoms. Conclusion Baseline symptoms were associated with worse OS but not with impaired treatment efficacy or more frequent AEs in mCRC patients treated with cetuximab in addition to chemotherapy., This study provides that the baseline patient‐reported symptoms are associated with worse OS, but not with impaired treatment efficacy or deteriorated AEs, for patients treated with cetuximab plus chemotherapy.

120 Background: Triplet regimen, FOLFOXIRI, plus bevacizumab is considered as one of standard first-line treatments in metastatic colorectal cancer (mCRC). On the contrary, FOLFOXIRI plus anti-EGFR antibody has been shown to be a promising regimen with greater depth of response (DpR) in patients with RAS wild-type mCRC from the VOLFI and MACBETH trials (J Clin Oncol 2019, JAMA Oncol 2018). We therefore performed a randomized phase II study, DEEPER trial (JACCRO CC-13) [NCT02515734], to investigate the efficacy and safety of cetuximab (cet) vs. bevacizumab (bev) in combination with modified (m)-FOLFOXIRI in previously untreated mCRC patients with RAS wild-type tumors. We have reported a significantly better DpR of m-FOLFOXIRI plus cet compared to bev as the primary endpoint (Tsuji A, et al. ASCO 2021). Methods: This trial was a randomized phase II trial to evaluate modified (m)-FOLFOXIRI (irinotecan 150 mg/m2, oxaliplatin 85 mg/m2, 5-FU 2400 mg/m2) plus cet vs. bev as initial treatment in terms of DpR during the entire course as the primary endpoint in 360 patients with RAS wild-type mCRC. The aim of the trial was to show that median DpR of cet arm was more than 12.5% higher than bev arm, with a power of 85% at a significance level of 0.05, in per protocol set (PPS) consisted of patients evaluable for the DpR. Secondary endpoints included progression-free survival, overall survival, overall response rate, early tumor shrinkage rate, secondary resection rate, and toxicity. A total of 359 patients were enrolled between July 2015 and June 2019. For the PPS (median age 65y, 64% male, PS0/1: 91%/9%, left/right primary: 84%/16%), 159 and 162 patients were randomly assigned to the cet and bev arms, respectively. Clinical outcomes will be analyzed according to primary tumor sidedness which is included in the stratification factor. Additionally, we will collect data of BRAF status, and analyze the clinical outcomes in mCRC patients with RAS/ BRAF wild-type tumors and/or left-sided tumors. Pre-planned survival analysis will be performed to compare the two treatment arms at the time of 3 years after last patients’ enrollment using a log-rank test. All statistical tests are two-sided, and P values ≤ 0.05 are deemed significant. Statistical analyses will be performed using SAS version 9.4. Clinical trial information: NCT02515734 .

Purpose Although early tumor shrinkage (ETS) is a predictor of improved overall survival (OS), the association between ETS and health-related quality of life (HRQOL) remains unclear for patients with metastatic colorectal cancer (mCRC) treated with first-line cetuximab plus chemotherapy. Methods The data were collected from a prospective trial that assessed HRQOL using the EORTC QLQ-C30. The impact of ETS on HRQOL was estimated using a linear mixed-effects model for repeated measures. Results ETS was achieved in 82 (64.1%) of 128 mCRC patients treated with first-line cetuximab plus chemotherapy, and these patients had a significantly longer OS than those without ETS (HR, 0.38; 95% CI, 0.20–0.72; P = .002). Asymptomatic patients with ETS had a favorable OS, while symptomatic patients without ETS had a worse OS (2-year OS rates, 77.8% vs. 42.5%). Symptomatic patients with ETS had similar outcomes as asymptomatic patients without ETS (2-year OS rates, 64.1% vs. 67.0%). For symptomatic patients, ETS was associated with improved HRQOL scores between baseline and 8 weeks: the mean changes for patients with and without ETS were 5.86 and -4.94 for global health status (GHS)/QOL, 26.73 and 3.79 for physical functioning, and 13.58 and -3.10 for social functioning, respectively. The improved HRQOL was comparable to that of asymptomatic patients without ETS. For asymptomatic patients, ETS showed a decreased deterioration in HRQOL. Conclusion Our findings highlight the importance of ETS for HRQOL and prognostic estimates, and assessing ETS may provide clinically useful information for physicians and patients to make more informed decisions.

Background Acute iliac arterial thrombosis during surgery is very rare complication. There were few reports on this complication relative to gastroenterological surgery, and the risk has not been recognized. Case presentation A 70-year-old man, diagnosed with a rectal cancer (adenocarcinoma of rectum) with known history heavy cigarette smoking with no known history of peripheral vascular disease underwent a laparoscopic abdominoperineal resection. He presented severe pain in the left leg in the recovery room. A computed tomography (CT) scan revealed the complete obstruction of the left common iliac artery. A successful revasculization was achieved through a thrombotectomy and percutaneous transluminal angioplasty with a stent immediately after the diagnosis. The pain in the left leg disappeared immediately after the revasculization. Conclusion An acute arterial thrombosis is a potential complication of the laparoscopic colorectal surgery with the lithotomy position.

86 Background: Triplet regimens, FOLFOXIRI, combined with bevacizumab (bev) or panitumumab have been shown to be superior in terms of early tumor shrinkage (ETS) and depth of response (DpR) compared to doublet regimen plus bev or triplet regimen in patients with RAS wild-type metastatic colorectal cancer (mCRC), in the TRIBE trial ( N Engl J Med 2014) or VOLFI trial ( J Clin Oncol 2019), respectively. There have been few studies which directly compared cetuximab (cet) with bev when combined with triplet regimen. Therefore, we investigated the efficacy and safety of bev vs. cet in combination with FOLFOXIRI in previously untreated mCRC patients with RAS wild-type tumors. Methods: This trial was a randomized phase II trial to evaluate modified (m)-FOLFOXIRI (irinotecan 150 mg/m2, oxaliplatin 85 mg/m2, 5-FU 2400 mg/m2) plus cet vs. bev as first-line treatment in terms of the DpR during the entire course as the primary endpoint in 360 patients with RAS wild-type mCRC (ClinicalTrials.gov Identifier: NCT02515734). The experimental arm with cet was considered to be active if the difference of median DpR was over 12.5% compared with the bev arm, under the conditions of significance level of 0.05 and power of 0.85. Secondary endpoints included the ETS at week 8, progression-free survival, overall survival, secondary resection rate, and toxicity. Results: A total of 359 patients were enrolled between July 2015 and June 2019. For the safety analysis set (median age 65y, 64% male, PS0/1:91%/9%, left/right primary:83%/17%), 173 and 175 patients were randomly assigned to the cet and bev arms, respectively, some patients were excluded for the safety analysis due to the violation of inclusion criteria (6 for cet arm and 5 for bev). On the cutoff date of September 2020, median number of cycles administered was 10 (range, 1-51) for the cet arm and 12 (range, 1-51) for the bev arm. The incidence of severe adverse events (AEs) was 25.4% (44/173) for the cet arm and 25.7% (45/175) for the bev arm, respectively. The following AEs of grade 3-4 were observed more frequently in the cet arm compared to the bev arm: oral mucositis (9.2% vs. 2.3%), diarrhea (12.1% vs. 8.0%), dermatitis acneiform (12.1% vs. 0%), and hypomagnesemia (4.0% vs. 0%). The treatment-related death occurred in 2 patients of the cet arm, while no patients in the bev arm. The rate of treatment discontinuation due to AEs of any cause was comparable between the cet and bev arms (7% vs. 9%). Conclusions: This safety analysis indicated that both regimens of m-FOLFOXIRI plus cet or bev were tolerable in RAS wt mCRC patients although some frequent severe AEs were observed. Clinical trial information: UMIN000018217.

A prospective trial has not been performed to investigate associations between quality of life (QOL), adverse events (AEs), and overall survival (OS) in the first‐line treatment with cetuximab plus standard chemotherapy for advanced/metastatic colorectal cancer (mCRC). Associations between patient outcome and health‐related QOL (HRQOL) together with skin toxicity‐related QOL were prospectively evaluated using EORTC QLQ‐C30 and DLQI questionnaires. One hundred and forty mCRC patients were analyzed in this study, and 87.8% received pre‐emptive skin treatment. Skin toxicity had no clinical impact on HRQOL or skin‐related QOL during the first 8 weeks and throughout the study period. An early skin reaction with a grade ≥2 at 8 weeks was significantly associated with a favorable OS compared with a grade of ≤1 (HR, 0.50; 95% CI, 0.24‐0.95; P = .035) and was confirmed to be an independent predictor of OS (HR, 0.48; 95% CI, 0.21‐0.97; P = .040). Patients symptomatic at baseline who responded to treatment had improved HRQOL compared to nonresponding patients. Severe mucositis/stomatitis had a statistically significant and clinically meaningful negative impact on HRQOL (mean changes from baseline throughout the study period in global health status were −12.64 for a grade of ≥2 vs −0.35 for a grade of 0 or 1 (P = .005)). In conclusion, severe early skin reactions predict favorable OS for patients treated with cetuximab plus chemotherapy without impairing QOL. In addition, mucositis/stomatitis was the most substantial AE compromising both QOL and treatment compliance.

Background FOLFOXIRI plus bevacizumab (bev) is one of preferred 1st-line regimens for RAS mutant metastatic colorectal cancer (mCRC); however, the original dosage is slightly toxic for Japanese patients (pts) due to frequent febrile neutropenia. We have reported that modified (m)-FOLFOXIRI (IRI 150mg/m2, OHP 85mg/m2, levofolinate 200mg/m2, and 5-FU 2400mg/m2 for 46-h continuous, up to 12 cycles followed by maintenance with 5-FU/levofolinate) plus bev has good objective response rate (ORR) of 76% as well as tolerability in Japanese pts with RAS mutant mCRC [Satake H, et al. Oncotarget 2018]. However, the follow-up time was short; therefore, clinical data was immature. Methods The primary endpoint was ORR. Progression-free survival (PFS), overall survival (OS), early tumor shrinkage (ETS), depth of response (DpR), and safety were secondary endpoints. The tumor shrinkage was evaluated every 8 weeks by the external review board. Pre-planned updated analysis was performed in January 2019. Results 62 pts (median 62.5-y old, 92% PS0, 90%/10% for KRAS/NRAS mutations, 27% right-side) were evaluable for efficacy and 63 pts for toxicity. The median cycle of treatment was 15 (range 1-46). Two pts still continued the protocol treatment and 40 (67%) pts received 2nd-line chemotherapy (triplet-regimen 28%, IRI-regimen+bev 23%, FOLFIRI+ramucirumab 15%, FOLFIRI+aflibercept 3%, OHP-regimen 10%, 5-FU+bev 10%, FTD/TPI 10%). Fourteen (23%) pts underwent surgery after protocol treatment. Median PFS was 11.9 (95%CI 9.5-14.0) months, median OS was 31.2 (95%CI 25.8-37.6), ETS was 73.8%, and median DpR was 49.2% (-28.7-100). Sub-analyses in each tumor side showed that ETS, DpR, median OS were 77.3%, 49.6%, 34.0 months in the left-side and 64.7%, 40.2%, 26.2 months in the right-side. No new adverse events were observed. Conclusions Updated analysis of the JACCRO CC-11 trial shows that m-FOLFOXIRI plus bev is a clinically useful regimen as a good option for RAS mutant mCRC.

Background Irinotecan have been well known to correlate between UGT1A1 polymorphisms (UGT1A1) and adverse events. Modified XELIRI (irinotecan 200 mg/m2 on day 1, capecitabine 1600 mg/m2 on days 1 to14 every 3 weeks) has shown non inferiority of overall survival compared with FOLFIRI based on "Asian XELIRI ProjecT" (AXEPT) as second line chemotherapy for patients with mCRC. In this preplanned analysis of the AXEPT trial, we evaluated the relationship between UGT1A1 and the efficacy and safety of irinotecan-based chemotherapy. Methods Patients were randomized FOLFIRI ± bevacizumab (BV) or modified XELIRI ± BV based on UGT1A1 results (wild type, heterozygosity, and homozygosity). With regard to irinotecan dosage in both treatment arms, the reduced dosage (150mg/m2) were administered in case of homozygosity. Assessed endpoints were overall survival (OS), progression free survival (PFS), overall response rate (ORR), relative dose intensity (RDI) and safety. Result UGT1A1 was available for all 650 randomized patients (wild type, 309 (47.5%) heterozygosity, 291 (44.8%) and homozygosity, 50 (7.7%)). Median OS was of patients with a wild/hetero/homo was 14.3, 18.3 and 9.1 months in FOLFIRI arm and 18.1, 16.3 and 13.0 months in mXELIRI arm, respectively. Median PFS of patients with a wild/hetero/homo was 6.8, 8.8 and 4.8 months in FOLFIRI arm and was 8.3, 8.7 and 6.5 months in mXELIRI arm, respectively. Grade 3, 4 toxicities of special interests (wild/hetero/homo) were neutropenia (35.9%/50.4%/45.8% in FOLFIRI arm and 17.0%/15.7%/21.7% in mXELIRI arm), febrile neutropenia (5.9%/2.3%/4.2% in FOLFIRI arm and 1.4%/4.3%/8.7% in XELIRI arm), and diarrhea (1.3%/6.0%/0% in FOLFIRI arm and 4.8%/10.7%/0% in mXELIRI arm). Conclusions mXELIRI±BV was showed the good efficacy and well tolerated in patients with all UGT1A1 polymorphisms. mXELIRI+BV could be an alternative to FOLFIRI as a standard second line backbone treatment for mCRC.

A 52-year-old female with a history of past surgery for arteriovenous malformation of the thoracic spinal cord presented with left chylothorax. Lymphangiography identified diffuse lymphatic vessel (LV) growth with ectasia at the left supradiaphragmatic level. On the right side, the LVs were absent due to previous surgery. Given the ineffectiveness of conservative management, the patient required surgery. Thoracotomy showed extensive pleural fibrosis, lung atelectasis, and diffuse chyle defluxion on the parietal pleura. The diffuse chyle defluxion was not resolved by ligation. Therefore, we performed pedicled omentoplasty to fill the pleural space and to utilize its drainage and angiogenic capacity. Two years after the procedure, there was no sign of relapse. There are very few reports of refractory chylothorax successfully treated by pedicled omentoplasty. The procedure would be useful for the treatment of chylothorax when non-surgical or typical surgical management fails.

症例は14歳，男性．突然の腹痛，嘔吐を主訴に発症．翌日，腸閉塞の診断で入院となった．腹部CT検査で総腸骨動脈分岐より3cm尾側でwhirl signを認め，その尾側の骨盤内に限局的に拡張した腸管を認め，壁の浮腫像と造影効果減弱を認めた．以上より絞扼性イレウスを疑い，入院当日緊急手術を施行した．イレウスの原因検索のために腹腔鏡下に腹腔内を観察した．骨盤内に先端が盲端で赤黒色に変色し拡張した管状構造物を認めMeckel憩室の軸捻転と診断した．捻転部直上の下腹部正中で小開腹をおきMeckel憩室の楔状切除を施行した．若年者で開腹既往のないイレウスの原因としてMeckel憩室は常に念頭に置くべき疾患であるが，術前診断が困難であることも多い．本症例では，腹腔鏡下にMeckel憩室の捻転と診断，最小限の小開腹下で手術が可能であり，腹腔鏡が診断治療に際し非常に有用であった．

症例は77歳,女性.患者は胆摘,臍部ヘルニア手術のあと近医で経過観察されていたが,腹痛を頻回に起こすようになり当院救急外来を受診した.腹部CT検査,小腸造影検査で第5腰椎付近の小腸に径3cmほどの憩室と小腸軸捻転症を認めた.入院後は腹痛発作は認めず,小腸憩室を伴った腸軸捻転症の診断で手術を行った.手術所見では,小腸は上腸間膜動・静脈を中心に反時計回りに捻転し,その軸の背側に小腸が嵌入していた.その嵌入した小腸を引き出すとTreiz靱帯から約50cmの空腸に径3cmほどの単発性憩室を認めた.手術は癒着剥離および小腸軸捻転解除,憩室楔状切除術を施行した.病理学的には憩室は真性憩室であった.術後経過は良好で第12病日に退院した.空腸憩室に伴う腸軸捻転症の症例は本邦で3例のみの報告がある稀な疾患であり,文献的考察を加えて報告した.

結腸癌の消化管結腸瘻は比較的稀であるが,小腸結腸瘻を合併した症例はさらに少ない.症例は78歳,女性.平成12年12月頃から少量の下血を認め,次第に軟便硬便を繰り返すようになった.平成13年9月下旬に腹痛を伴ったため近医を受診し,貧血を指摘され10月3日当院紹介入院となった.体重は1年で15kg減少し55kgであった.入院時検査では,著明な小球性低色素性貧血と腫瘍マーカ高値を認めた.大腸内視鏡検査では2型進行癌を認めたが瘻孔は確認できなかった.注腸造影検査にて瘻孔を介しての小腸造影所見を認めた.他の画像検査では明らかな転移性腫瘍は認めなかった. S状結腸癌による小腸結腸瘻と診断し, 10月24日S状結腸切除,小腸合併切除術を行った.腫大した小腸間膜リンパ節には転移を認め同時に切除した.術後28カ月無再発にて経過観察中である.消化管結腸瘻を形成した結腸癌症例は,比較的限局しており合併切除により良好な予後を期待できる.

症例は43歳,女性.平成12年1月頃より腹痛を自覚.その後腹痛の増悪に加え腹部膨満感,嘔気を認めたため, 1月31日当院救急外来を受診.腹部CT検査等で回腸末端付近の腫瘤性病変による腸閉塞と診断し,入院となった.本症例は,腫瘤性病変に対する腹部MRI検査で, T1強調像および脂肪抑制T1強調像で高信号, T2強調像で低信号を呈し血腫を伴った腫瘤が考えられたため,術前に腸管子宮内膜症と診断し,手術を施行した.腸管子宮内膜症は,転移性消化管腫瘍などとの鑑別も含め術前診断が困難であった症例の報告が多いが, MRI検査による術前の検討が,腸管子宮内膜症の診断に有用であると考えられた.

TPS818 Background: The FIRE-3 study proved that early tumor shrinkage (ETS) and DpR were superior with FOLFIRI plus cetuximab (cet) compared to bevacizumab (bev) in mCRC patients with RAS wild-type tumors (Stintzing S, et al. Lancet Oncol 2016). A retrospective analysis of treatment groups between FOLFOXIRI plus anti-EGFR antibody and bev showed significantly better DpR and ETS in the anti-EGFR antibody group (48.6% vs. 37.8% for the median DpR; 40.8% vs. 26.4% for the median ETS)(Salvatore L, et al. ESMO 2014). However, there have been few studies comparing cet with bev in combination with the FOLFOXIRI regimen used as a platform. Therefore, it is great interest to investigate whether cet will be more beneficial than bev when combined with the triplet regimen as a promising treatment option. Methods: Key eligibility criteria are as follows: histologically proven unresectable metastatic/recurrent CRC; RAS wild-type tumors; patients who have not received any prior chemotherapies or patients with relapse after at least 12 months following adjuvant chemotherapy. Primary endpoint of this study is the DpR until progression. Key secondary endpoints are the ETS at Week 8, progression-free survival, overall survival, and safety. After randomization, patients receive up to 12 cycles of FOLFOXIRI (irinotecan: 150 mg/m2, oxaliplatin: 85 mg/m2, l-levofolinate: 200 mg/m2, continuous fluorouracil: 2400 mg/m2, every two weeks) plus cet (initial: 400 mg/m2, subsequent: 250 mg/m2, weekly) or bev (5 mg/kg, every two weeks) as induction treatment. Thereafter, fluorouracil, l-levofolinate, and cet or bev are administrated as maintenance treatment. Based on previous reports, the difference of 12.5% in the median DpR between the cet and bev groups was assumed. Each standard deviation was estimated to be 42% (cet group) and 34% (bev group). Under the conditions of significance level of 0.05 for a two-sided test and power of 0.85, the required sample size was calculated to be 360 patients. Thirty-three patients have been enrolled by August 2016. Clinical trial information: 000018217.

A 38-year-old man with complaints of nausea, epigastralgia, cough, and decrease body weight was given a diagnosis of advanced gastric cancer (type 4) with carcinomatous lymphangitis of the lung (UM-circ cT3, N3, H0, P0, M1, stage IV, por2). He was treated with combination of docetaxel (DOC) 40 mg/m(2)/day (days 1, 15) and S-1 orally 80 mg/m(2)/day (days 1-7, 15-21), 1 week administered 1 week rest. After 2 courses of treatment, the patient achieved a partial response in the carcinomatous lymphangitis of the lung. Tumor markers decreased and symptoms improved. He experienced grade 2 peripheral neuropathy but with no grade 3 adverse events. Although the prognosis of gastric cancer with carcinomatous lymphangitis is poor. These results indicate that bi-weekly DOC and S-1 combination chemotherapy might be effective for gastric cancer with carcinomatous lymphangitis of the lung.

A 61-year-old man with the chief complaint of pressure with swallowing was referred to our hospital with type 3 cardiac gastric cancer. Gastrofiberscope showed type 3 cardiac cancer with esophageal invasion. On the abdominal computed tomography, there was evidence of lymph node swelling in the lesser curvature and multiple liver metastases. Blood tumor markers were elevated: CEA 200 ng/mL, CA19-9 2,490 U/mL. He was diagnosed as unresectable advanced gastric cancer UE-circ, type-3, c-T3N2H1P0M1, Stage IV. A biopsy revealed adenocarcinoma (tub2-por1). We started bi-weekly docetaxel and S-1 combination chemotherapy(DOC 40 mg/m2 day 1, 14, S-180 mg/m2 day 1-7, 14-21). After completion of the first course of this combination therapy, his feeling of pressure was relieved and CT showed reduction of multiple liver lesions and lymph node metastases, indicating partial response. No regrowth was seen for 7 courses of the therapy. Regarding toxicity, grade 2 nausea and grade 1 nail pain were observed. After 7 courses, because of serum CEA elevation, bi-weekly CPT-11/CDDP therapy (CPT-11 60 mg/m2, CDDP 30 mg/m2) was administered followed by weekly PTX therapy (65 mg/m2 day 1, 7, 14; total of 4 weeks). To date, 17 months after administration of chemotherapy, he has been treated on an outpatient basis. Biweekly DOC/S-1 therapy can be novel antitumor therapy which can be conducted safely in an outpatient setting for advanced gastric cancer.