tbuckley/cabot-search huggingface dataset:
Recurrence in ovarian carcinoma stage I A/B grade 1 and 2 with and without chemotherapy
Authors: F. Simpkins, F. Abu Shahim, J. N. Bakkum-Gamez, M. B. Jones, R. P. Rocconi, K. S. Mathews, K. N. Moore, D. N. Fong, P. G. Rose
Journal: Journal of Clinical Oncology (2007)

5565 Background: The goal of this study was to determine the recurrence rates (R) of patients with grade 1 and 2 stage 1A and IB ovarian tumors treated with and without chemotherapy. Methods: We conducted a five-center retrospective study of patients with Stage 1A/B grade 1 and 2 ovarian carcinoma. All women underwent comprehensive staging including a minimum of unilateral salpingo-ophorectomy, unilateral pelvic and para-aortic lymphadenectomy, and omentectomy. Clear cell histologies were classified as grade 3 and excluded. The minimum cancer-free survivor follow-up was 3 years. Results: We identified 82 patients with Stage 1A/B grade 1 and 2 who met criteria for the study. The median age was 58 yrs (range 29 to 83) and the median follow-up was 5.3 yrs (range 3 to 11 yrs). The majority were of endometrioid histology (51), followed by mucinous (19), papillary serous (11), and mixed (1). Recurrences were of endometrioid (4), mucinous (1), or papillary serous (1) histology. For Stage 1A, overall recurrence rate was 9% (6/67). The overall recurrence rates for Stage 1A, grade1 tumors was 6% and among grade 2 tumors 12% (p=0.40). Among Stage 1A patients not treated with chemotherapy, there was a 7% (2/29) and 9.5% (2/21) recurrence rate for grade 1 and grade 2 tumors, respectively. For the grade 1 tumors, both patients are alive with disease at 3 and 5 yrs. For the grade 2 tumors, one is alive without evidence of disease at 7 yrs and the other died from disease at 4 yrs. Time to recurrence (TTR) was 2.3 yrs for grade 1 tumors and 2.6 yrs for grade 2 tumors. For Stage 1A patients treated with a platinum chemotherapy regimen, there were no recurrences (0/5) for grade 1 tumors and a 16% (2/12) recurrence rate for grade 2 tumors. Of the recurrences, one patient died from disease at 1.4 yrs and the other is alive with stable disease at 6 yrs. Time to recurrence was 2.85 yrs for grade 2 tumors. For grade 1 or 2, Stage 1A tumors, recurrence rates and time to recurrence were not effected by chemotherapy administration (R, p=0.55 and p=0.54, respectively; TTR, grade 2, p=0.85). No recurrences were observed in the 15 patients with Stage IB, grade 1 and 2 tumors. Conclusions: In comprehensively staged patients with Stage 1A/B, grade 1 and 2, low recurrence rates suggest adjuvant chemotherapy may not be indicated. No significant financial relationships to disclose.
MITO-11: A randomized multicenter phase II trial testing the addition of pazopanib to weekly paclitaxel in platinum-resistant or -refractory advanced ovarian cancer (AOC).
Authors: Sandro Pignata, Domenica Lorusso, Giovanni Scambia, Daniela Sambataro, Stefano Tamberi, Saverio Cinieri, Anna Maria Mosconi, Michele Orditura, Stefania Bartolini, Valentina Arcangeli, Pierluigi Benedetti Panici, Carmela Pisano, Sabrina Chiara Cecere, Marilena Di Napoli, Francesco Raspagliesi, Vanda Salutari, Gennaro Daniele, Maria Carmela Piccirillo, Ciro Gallo, Francesco Perrone
Journal: Journal of Clinical Oncology (2014)

5503^ Background: few drugs are available for patients (pts) with platinum resistant or refractory AOC; their efficacy is scanty. Evidence on antiangiogenic drugs efficacy in AOC is increasing. Pazopanib is an oral multi-kinase inhibitor of VEGFR-1, -2, -3, PDGFR-α and -β and c-Kit with antiangiogenic properties. Methods: AOC pts with disease progressing during or within 6 months from the last platinum-based chemotherapy, aged≤75, ECOG PS 0-1 were eligible for a multicenter comparative randomized phase 2 trial of weekly paclitaxel (wP, 80 mg/m² dd 1, 8, 15 q 28) vs wPP (wP + pazopanib 800 mg/day); both treatments could continue until progression. Primary endpoint was progression-free survival (PFS). With 61 events, the trial would have 80% power to detect a 0.65 hazard ratio (HR), prolonging median PFS from 3 to 4.6 months with one-tail alfa = 0.20; 72 pts were planned. Partially supported by GSK. Clinicaltrials.gov NCT 01644825. Results: 74 pts (37 in each arm) were enrolled by 11 centers. Median age 57; 46% had received only one prior platinum based treatment; 24% were platinum-refractory; no pt had received prior bevacizumab. As of Jan 24, 2014, with median follow-up 12.5 months (95% CI 11.6-16.3), 66 PFS events and 34 deaths were recorded. Median PFS was 3.5 months (95% CI 2.0-5.7) with wP and 6.3 months (95% CI 5.4-11.0) with wPP; log-rank test one-tail p=0.0008; HR 0.45 (95% CI 0.27-0.75). Median overall survival was 14.8 months (95% CI 9.1-NA) with wP and 18.7 months (95% CI 11.5-NA) with wPP; p=0.07; HR 0.60 (95% CI 0.30-1.21). There was no toxic death. Neutropenia (Wilcoxon-Mann-Whitney exact test p=0.0007), hypertension (p<0.0001), diarrhoea (p=0.0002), mucositis (p=0.0007), AST/ALT (0.019), sensory neuropathy (p=0.025), and other neurologic events (p= 0.023) were more frequent and severe with pazopanib. Any grade 3-4 toxicity occurred in 8 (22%) pts with wP and 20 (54%) with wPP (Chi-square p=0.0052). Conclusions: The addition of pazopanib to wP in the treatment of pts with platinum-resistant or refractory advanced ovarian cancer might produce a significant prolongation of PFS and OS. A phase 3 trial is strongly supported. Clinical trial information: NCT 01644825.
Abstract P086: Ideal Cardiovascular Health and Depressive Symptoms in the Adult Population
Authors: Vanesa España-Romero, Enrique G Artero, Duck-chul Lee, Xuemei Sui, Meghan Baruth, Jonatan R Ruiz, Russell R Pate, Steven N Blair
Journal: Circulation (2012)

Introduction: Ideal cardiovascular health is a new construct defined by the American Heart Association as part of its 2020 Impact Goal. The World Health Organization recognizes depression as 1 of its 10 most important global public health issues. We hypothesized that the simultaneous presence of ideal cardiovascular health behaviors and factors could reduce the risk of depressive symptoms. Methods: Participants were examined between 1987 and 1998 and followed for a median period of 6 years. Ideal cardiovascular health behaviors (never smoking, body mass index [BMI] &lt;25 kg/m2, physical activity at goal, and appropriate diet consistent with a DASH-type eating plan) and factors (total cholesterol &lt;200mg/dL, blood pressure &lt;120/80 mm Hg, and fasting blood glucose &lt;100 mg/dL) were measured at baseline. Depressive symptoms were assessed using the 10-item Center for Epidemiologic Studies Depression Scale (CES-D) in 1990, 1995 or 1999 and a score of 8 or greater was considered having depressive symptoms. Results: From a total of 5110 participants, 641 reported depressive symptoms. Participants meeting 3–4 or 5–7 ideal cardiovascular health components had a 28% (odds ratio, OR= 0.72, 95% confidence interval, 95% CI=0.59 – 0.87) and 36% (OR= 0.64, 95% CI=0.50 – 0.82) lower risk of depressive symptoms, respectively, compared with those meeting 0–2 components. Ideal behaviors were associated with lower risk of depressive symptoms: OR= 0.81, 95% CI=0.67–0.98 and OR= 0.72, 95% CI=0.57–0.91 in participants meeting 2 or 3–4 ideal behaviors, compared with those meeting 0–1. Individual or combination of ideal factors was not associated with depressive symptoms. Conclusion: Ideal cardiovascular health, especially health behaviors, may be useful for predicting depressive symptoms.
Abstract 9726: Prolonged Insulin Secretion After Oral Glucose Load is Associated With Severity of Coronary Artery Disease
Authors: Makoto Murata, Hitoshi Adachi, Noriaki Takama, Yusuke Sawada, Kuniko Masuda, Kohji Kurosawa, Ryuichi Funada, Ryotaro Seki, Ren Kawaguchi, Takuji Toyama, Hiroshi Hoshizaki, Shigeru Ohshima, Masahiko Kurabayashi
Journal: Circulation (2012)

Introduction: Hyperglycemia exerts its direct detrimental effects toward the progression of atherosclerosis. However, the role of hyperinsulinemia in the development of atherosclerosis remains to be determined. Little is known about the relationship between cardiovascular events and plasma insulin levels. Hypothesis: We hypothesize that hyperinsulinemia is associated with the severity of coronary atherosclerosis. Methods: Three hundred and forty four consecutive patients (mean age 63±14 SD years; 272 male patients, 72 female patients) who underwent coronary angiography and 2-h 75-g oral glucose tolerance test (OGTT) from April 2006 to January 2012 were enrolled. We excluded the patients with left main trunk lesion, or prior diagnosed diabetes. Based on the number of stenotic vessels, the patients were classified into 4 groups; 0 vessel disease (VD) (n=35), 1VD (n=142), 2VD (n=92), and 3VD (n=36). We measured plasma glucose and insulin levels after 75-g oral glucose load. Results: Baseline characteristics were similar among the 4 groups with respect to age, gender, medications, and each of major coronary risk factors. There were no differences glucose profiles in 75-g OGTT, homeostasis model assessment-insulin resistance (HOMA-IR), HOMA-β and HbA1c among these groups (Figure 1A). However, insulin secretion was higher in 2VD and 3VD groups at 120 min whereas no significant difference in insulin secretion at 0, 30 and 60 min (Figure 1B). Furthermore, insulinogenic index at 120 min was increased in 2VD (1.21±1.05[p&lt;0.001]) and 3VD (1.14±0.5l[p=0.002]) compared with 0VD despite of no significant difference in common insulinogenic index. Conclusions: Despite no significant difference in insulin resistance and postprandial hyperglycemia prolonged insulin secretion was associated with multivessel coronary artery disease. Prolonged postprandial hyperinsulinemia may promote progression of atherosclerosis.
Macrophage Phenotype and Function in Different Stages of Atherosclerosis
Authors: Ira Tabas, Karin E. Bornfeldt
Journal: Circulation Research (2016)

The remarkable plasticity and plethora of biological functions performed by macrophages have enticed scientists to study these cells in relation to atherosclerosis for &gt;50 years, and major discoveries continue to be made today. It is now understood that macrophages play important roles in all stages of atherosclerosis, from initiation of lesions and lesion expansion, to necrosis leading to rupture and the clinical manifestations of atherosclerosis, to resolution and regression of atherosclerotic lesions. Lesional macrophages are derived primarily from blood monocytes, although recent research has shown that lesional macrophage-like cells can also be derived from smooth muscle cells. Lesional macrophages take on different phenotypes depending on their environment and which intracellular signaling pathways are activated. Rather than a few distinct populations of macrophages, the phenotype of the lesional macrophage is more complex and likely changes during the different phases of atherosclerosis and with the extent of lipid and cholesterol loading, activation by a plethora of receptors, and metabolic state of the cells. These different phenotypes allow the macrophage to engulf lipids, dead cells, and other substances perceived as danger signals; efflux cholesterol to high-density lipoprotein; proliferate and migrate; undergo apoptosis and death; and secrete a large number of inflammatory and proresolving molecules. This review article, part of the Compendium on Atherosclerosis , discusses recent advances in our understanding of lesional macrophage phenotype and function in different stages of atherosclerosis. With the increasing understanding of the roles of lesional macrophages, new research areas and treatment strategies are beginning to emerge.
Do Young Age and Triple Negative Molecular Subtype Have a Negative Effect on Survival in Patients with Early Stage Breast Cancer?
Authors: C. Ordu, A. Bozdogan, G. Alco, K.N. Pilanci, D. Selamoglu, F. Agacayak, Z. Erdogan, S. Ilgun, F. Elbuken, S. Igdem, S. Okkan, V. Ozmen
Journal: Annals of Oncology (2014)
Engineered T-Cells Expressing An HLA-Restricted Affinity-Enhanced TCR In Advanced Multiple Myeloma Patients Post Auto-SCT Engraft and Are Associated With Encouraging Post Auto-SCT Responses
Authors: Aaron P. Rapoport, Edward A. Stadtmauer, Dan T. Vogl, Brendan M Weiss, Gwendolyn K. Binder-Scholl, Dominic P. Smethurst, Jeffrey Finklestein, Irina Kulikovskaya, Minnal Gupta, Joanna E. Brewer, Alan D. Bennett, Andrew B. Gerry, Nicholas J. Pumphrey, Helen K. Tayton-Martin, Lilliam C. Ribeiro, Ashraf Badros, Saul Yanovich, Gorgun Akpek, Naseem Kerr, Sunita Philip, Sandra Westphal, Bruce L. Levine, Bent K. Jakobsen, Michael Kalos, Carl H. June
Journal: Blood (2013)
The validity of health-related quality of life questionnaires in bronchiectasis: a systematic review and meta-analysis
Authors: Arietta Spinou, Konstantinos C Fragkos, Kai K Lee, Caroline Elston, Richard J Siegert, Michael R Loebinger, Robert Wilson, Rachel Garrod, Surinder S Birring
Journal: Thorax (2016)

<h3>Background</h3> A range of questionnaires have been used to assess health-related quality of life (HRQOL) in bronchiectasis. A systematic review was conducted to evaluate their psychometric properties and assess associations between HRQOL and clinical measures. <h3>Methods</h3> Five electronic databases were searched. Studies eligible for inclusion were those that investigated the validity of HRQOL questionnaires and/or their association with other outcomes in adults with bronchiectasis. Patients with cystic fibrosis were excluded. The identified questionnaires were assessed for convergent, discriminant and cross-cultural translation validity; missing data, floor and ceiling effects, internal consistency, responsiveness and test-retest reliability. A meta-analysis was conducted to estimate the strength of associations between HRQOL and clinical measures. <h3>Results</h3> From 1918 studies identified, 43 studies were included in the systematic review, of which 38 were suitable for the meta-analysis. Nine HRQOL questionnaires were identified, with the most widely used being: St George9s Respiratory Questionnaire, Leicester Cough Questionnaire, Quality of Life–Bronchiectasis and Short Form-36. HRQOL questionnaires had moderate to good internal consistency and good test-retest reliability. Only 8 of 18 studies that used translated HRQOL questionnaires reported or referred to the validity of the translated questionnaire. There was a stronger correlation (mean r (95% CI)) between HRQOL and subjective outcome measures, such as dyspnoea (0.55 (0.41 to 0.68)) and fatigue (0.42 (0.23 to 0.58)) compared with objective measures; exercise capacity (−0.41 (−0.54 to −0.24)), FEV<sub>1</sub>% predicted (−0.31 (−0.40 to −0.23)) and extent of bronchiectasis on CT scan (0.35 (0.03 to 0.61)); all p&lt;0.001. <h3>Conclusions</h3> This review supports most HRQOL questionnaires used in bronchiectasis have good psychometric properties. There was a weak to moderate association between HRQOL and objective outcome measures. This suggests that HRQOL questionnaires assess a unique aspect of health not captured by objective measures.
Long-term survival of patients (pts) with advanced melanoma treated with ipilimumab with or without dacarbazine
Authors: E. Hersh, J. Weber, J. Powderly, A. Pavlik, G. Nichol, M. Yellin, L. Cranmer, W. Urba, S. O'Day
Journal: Journal of Clinical Oncology (2009)

9038 Background: Ipilimumab is a fully human monoclonal antibody targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4). Here, we report updated survival of pts with advanced melanoma treated with ipilimumab in 2 completed studies. Methods: Seventy-two chemotherapy-naïve pts were randomized to receive 3 mg/kg ipilimumab every 4 weeks (Q4W) × 4 alone or with ≤6 × 5-day courses of DTIC 250 mg/m 2 /day (ipilimumab, n = 37; ipilimumab + DTIC, n = 35) in the multicenter, open- label Phase II study MDX010–08 (Sep 2002-Aug 2004)(Hersh E et al. J Clin Oncol 26: 2008 (May 20 suppl; abstr 9022)). In the phase I/II dose-ranging study MDX010–15, 23 pts were treated with 10 mg/kg ipilimumab every 3 weeks (Q3W) × 4 (induction) (Jun 2004- Jul 2006) (Urba W et al. J Clin Oncol 26: 2008 (May 20 suppl; abstr 3018)). No maintenance ipilimumab was administered in either study. Long-term survival was determined under a follow-up protocol (MDX010–28) from May 2007-Jan 2008. Results: Long-term data are available for 62 pts for MDX010–08 and 22 pts for MDX010–15. For MDX010–08, the median follow-up was 4.3 years (range, 4.0–4.7 years); it was 2.2 years (range, 2.0–2.4 years) for MDX010–15. Survival rates are reported in the Table . Conclusions: Ipilimumab monotherapy, administered at 3 mg/kg and without maintenance dosing, resulted in survival rates better than those observed with historical controls (Korn EJ et al. J Clin Oncol 26:527–34; 2008). Adding DTIC to ipilimumab did not suppress the effect of ipilimumab (as might have been predicted), but enhanced it still further. Consistent with previously reported response data showing that 10 mg/kg is the recommended dose (study CA184022) (Hamid O et al. J Clin Oncol 26: 2008 (May 20 suppl; abstr 9025)), there was a trend toward better survival with the higher dose (eg, a 2-year survival rate of 36% vs. 22% for 10 mg/kg vs. 3 mg/kg). [Table: see text] [Table: see text]
A prospective phase III, randomized, double‐blind, placebo‐controlled study of brodalumab in patients with moderate‐to‐severe plaque psoriasis
Authors: K.A. Papp, K. Reich, C. Paul, A. Blauvelt, W. Baran, C. Bolduc, D. Toth, R.G. Langley, J. Cather, A.B. Gottlieb, D. Thaçi, J.G. Krueger, C.B. Russell, C.E. Milmont, J. Li, P.A. Klekotka, G. Kricorian, A. Nirula
Journal: British Journal of Dermatology (2016)

The interleukin‐17 cytokine family plays a central role in psoriasis pathogenesis. To evaluate the efficacy and safety of brodalumab, a human anti‐interleukin‐17 receptor antibody, in treating patients with moderate‐to‐severe plaque psoriasis. In this phase III, double‐blind, placebo‐controlled study (NCT01708590; AMAGINE‐1), adult patients in the U.S.A., Canada and Europe were randomized to brodalumab (140 or 210 mg) or placebo every 2 weeks (Q2W), with an additional dose at week 1, for a 12‐week induction phase. At week 12, patients receiving brodalumab who achieved static Physician's Global Assessment 0 or 1 (sPGA success) were rerandomized to the placebo or induction dose. After week 16, patients with sPGA ≥ 3 were re‐treated with the induction dose. After ≥ 12 weeks of retreatment, patients with sPGA 2 for ≥ 4 weeks or sPGA ≥ 3 were rescued with brodalumab 210 mg Q2W. At week 12, patients randomized to brodalumab with sPGA ≥ 2 or placebo received brodalumab 210 mg Q2W. Coprimary end points were the percentage of patients with ≥ 75% improvement in Psoriasis Area and Severity Index score (PASI 75) and sPGA success at week 12. There were 661 patients randomized: 220 placebo, 219 brodalumab 140 mg and 222 brodalumab 210 mg. At week 12, 60% (140 mg) and 83% (210 mg) vs. 3% (placebo) achieved PASI 75, and 54% (140 mg) and 76% (210 mg) vs. 1% (placebo) achieved sPGA success. The safety profile was considered acceptable. Brodalumab therapy resulted in significant clinical benefit and an acceptable safety profile in patients with moderate‐to‐severe plaque psoriasis.
p63/p73 expression mediates cisplatin sensitivity in a subset of triple-negative primary breast cancer: Implications for a new clinical trial
Authors: S. J. Isakoff, C. Leong, N. Vidnovic, M. P. DeYoung, D. Sgroi, P. E. Goss, P. D. Ryan, L. W. Ellisen
Journal: Journal of Clinical Oncology (2007)

10522 Background: Triple-negative breast cancer (ER-, PgR- and HER2-negative) has a poor prognosis relative to other subtypes, even with the best available chemotherapy. We recently reported that in squamous cell cancers, p63 promotes survival by direct interaction with and inhibition of p73-dependent apoptosis. We now report on the role of p63/p73 in triple-negative breast cancer. Methods: We performed quantitative RT-PCR on primary breast cancer specimens to determine the expression of specific p63 and p73 isoforms. Cell culture experiments used MCF7, HCC-1937, MDA-MB-468, T47D, and MCF10A cell lines. Lentiviral p63 and p73 shRNA were used for knockdown experiments. Chemotherapy dose-response curves were generated using MTT assay. Results: In primary tumors, ΔNp63 and TAp73 isoforms are expressed exclusively within a subset of triple-negative tumors in which p53 mutations are commonly found. Knockdown of p63 in triple-negative cell lines, but not the ER-positive MCF7 line, induced apoptosis which was specifically dependent on p73 expression. Breast cancer cell lines expressing p63/p73 exhibited p73-dependent sensitivity to cisplatin. Knockdown of p73 resulted in a 10–100 fold increase in the IC50 of cisplatin, but no change in doxorubicin or paclitaxel sensitivity. Exogenous p73 expression in MCF10A cells, which have high levels of p63 but no p73, confers increased sensitivity to cisplatin. Conclusion: These results show that p63/p73expression promotes survival in a subset of breast cancers, and they provide a mechanism for cisplatin sensitivity. These findings suggest that p63/p73 expression may serve as a biomarker to predict cisplatin sensitivity in triple-negative breast cancer. Based on these results, we are conducting a phase II study of 39 patients evaluating cisplatin as first line therapy for metastatic triple-negative breast cancer. The primary endpoints are overall objective response rate and response rate in low versus high p63/p73 expressing subgroups. No significant financial relationships to disclose.
A phase II trial of 5-weekly S-1 plus cisplatin (CDDP) combination with trastuzumab (Tmab) for HER2-positive advanced gastric or esophagogastric junction (EGJ) cancer: WJOG7212G (T-SPACE) study.
Authors: Yuji Miura, Toshimi Takano, Yasutaka Sukawa, Katsuhiko Nosho, Shuichi Hironaka, Misuzu Mori, Kazuhiro Nishikawa, Shinya Tokunaga, Hiroyuki Okuda, Masahiro Tsuda, Keisei Taku, Kazuo Nishikawa, Toshikazu Moriwaki, Kenichi Yoshimura, Narikazu Boku, Ichinosuke Hyodo
Journal: Journal of Clinical Oncology (2015)

126 Background: Five-weekly schedule of S-1 plus CDDP (5-weekly SP) is the standard first-line chemotherapy for the patients (pts) with advanced gastric cancer (AGC) in Japan. Tmab with fluoropyrimidine plus CDDP chemotherapy has shown a survival benefit for pts with HER2-positive AGC and EGJ cancer. However, little information on the efficacy and safety of 5-weekly SP combined with Tmab is available. Methods: We conducted a prospective, single arm, multicenter, phase II trial of 5-weekly SP (S-1 40-60 mg bid for 21 days plus CDDP 60 mg/m 2 on day 8, every 5 weeks) combined with Tmab (8 mg/kg as a loading dose then 6 mg/kg, every 3 weeks) for pts with HER2-positive (IHC 3+ or IHC 2+ and FISH positive) AGC or EGJ cancer. Primary endpoint was response rate (RR) evaluated by independent review committee, using RECIST v1.1. Secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety. With power of 80% and one-sided alpha of 10%, thirty-five pts were required to reject 40% of RR under expected 60% RR. During the study, protocol was amended based on the favorable accrual rate. Pts were enrolled over 35 to improve precision, until pts enrollment up to 55 (power 85% and alpha 5%) or the end of predetermined accrual period, whichever came first. Results: Between August 2012 to January 2014, 44 pts were enrolled. Pts’ characteristics were: males 34 (77%), median age 62.6 years, PS 0-1 42 (95%), primary tumor site of stomach 37 (84%), histology of diffuse type 18 (41%). IHC 3+ was recorded in 32 (73%) pts. The RR was 64% (95% CI 48-78, one-sided p&lt;0.001). The median PFS was 6.0 months (95% CI 5.1-10.9). The median OS was not reached. The toxicities in the first four courses were assessed. The most common grade 3 to 4 adverse events were anorexia (23%), diarrhea (11%), neutropenia (23%), anemia (16%), and thrombocytopenia (11%). One (2%) treatment-related death was reported. Conclusions: 5-weekly SP combined with Tmab showed a good efficacy with acceptable toxicities for pts with advanced AGC or EGJ cancer. Clinical trial information: UMIN000008389.