bluuebunny/crossref_metadata_2025_split huggingface dataset:
Retrospective cohort study on the safety and efficacy of panitumumab for patients with metastatic colorectal cancer: The HGCSG1002 study—Analysis of after cetuximab refractory.
Authors: Kobayashi Yoshimitsu , Fukushima Hiraku , Sasaki Takahide , Yuki Satoshi , Okuda Hiroyuki , Kusumi Takaya , Doi Ayako , Tsuji Yasushi , Hatanaka Kazuteru , Uebayashi Minoru , Koike Masahiko , Kato Takashi , Nakamura Michio , Sato Yasushi , Ohta Tomoyuki , Kudo Mineo , Konno Jun , Iwai Kazuhiro , Sakata Yuh , Komatsu Yoshito ,   Hokkaido Gastrointestinal Cancer Study Group
Published: February 2017

541 Background: In the previous studies, panitumumab (Pmab) has been demonstrated the efficacy for patients with metastatic colorectal cancer (mCRC) in all treatment lines. It is still controversial about the efficacy of Pmab for patients that had progressed on prior cetuximab (Cmab), though there had been a few reports (from Metges et al. and Wadlow et al.) regarding the efficacy of Pmab after Cmab refractory or intolerance. To evaluate the efficacy and safety of Pmab in patients with cetuximab-refractory mCRC, in comparison with anti-EGFR antibody naïve patients (Cmab-naïve) and Cmab-refractory or intolerance patients (prior-Cmab). Methods: Two hundred patients with mCRC treated by Pmab contained chemotherapy were retrospectively registered from 20 centers in Japan (HGCSG 1002 study). Of these, the patients that were refractory to or intolerant for 5-FU/ irinotecan/ oxaliplatin, and were administered Pmab monotherapy were included in this analysis. Results: Of 93 patients (44 prior-Cmab and 49 Cmab-naïve) were evaluated. There were no significant differences in the baseline characteristics of the patients in each group. The incidence of Grade 3 or higher any skin toxicities were higher in the Cmab-naïve (26.5.%) than in the prior-Cmab (11.4%). The overall response rate (RR) was not significantly difference (prior-Cmab/ Cmab-naïve, 9.1%/ 10.2%), but the disease control rate (DCR) was slightly higher in Cmab-naïve group (38.6%/ 55.1%, p=0.15). Progression free survival (PFS) and overall survival (OS) were follows: prior-Cmab/ Cmab-naïve, 2.8m/ 3.1m, 6.8m / 9.5m. There was a significant difference between the two groups in OS curve (p=0.04). Conclusions: Pmab was safely administered to heavily pretreated mCRC patients in daily practice. Although there were no significant differences in RR, DCS and PFS between prior-Cmab and Cmab-naïve, but the median OS was longer for the Cmab-naïve group compared with the prior-Cmab group. Therapeutic efficacies of Pmab for prior-Cmab patients did not comparable to those for Cmab-naïve patients. We are now performing a phase II trial on the efficacy of Pmab for Cmab-refractory mCRC patients.
Pathologic tumor and normal mucosa responses after hyperfractionated versus hypofractionated preoperative radiotherapy for rectal cancer.
Authors: Suwinski Rafal , Stobiecka Ewa , Chmielik Ewa , Kryj Mariusz , Chmielarz Andrzej , Widel Maciej , Idasiak Adam , Bialas Marcin , Wydmanski Jerzy , Wzietek Iwona 
Published: February 2017

556 Background: The aim of the study is to assess radiation-induced tumor and normal mucosa responses in patients who underwent preoperative radiotherapy according to two different fractionation protocols. This research constitutes one of the secondary endpoints of a prospective randomized trial. Methods: Pathological samples after preoperative radiotherapy and surgery were obtained from 106 patients: 50 were treated with hypofractionation 39 Gy in 3.0 Gy per fraction (HYPO) and 56 with accelerated hyperfractionation 42 Gy given in two daily fractions of 1.5 Gy with a minimal interfraction interval of 6 hours (HART). This sample represents approximately 30% of an overall trial size. Over 50 pathological features were assessed for each sample including tumor/nodal response, normal mucosa and cellular matrix response, ulceration and morphology of tumor cells. The observed grades of responses in HYPO vs. HART were compared using U Mann-Whitney test. Results: The primary tumor downstaging was observed in 41% vs. 35% of the patients treated with HYPO and HART respectively, the difference was not significant (p=0.5). By contrast, a trend towards improved nodal response among the patients treated with HYPO was recorded, with 94% achieving complete or major nodal response, compared to 73% in HART (p=0.03). Mucosal atrophy and edema were significantly higher in HYPO (p=0.003 and p=0.02, respectively). A trend for increased mucosal inflammation was also recorded in HYPO (p=0.06). Tumor/nodal responses were not significantly influenced by time-interval radiotherapy-surgery (below or above the median of 11 days), however, more cellular injury to normal mucosa (atrophy, ulceration) was observed at short RT-surgery intervals (p=0.01). Conclusions: Radiation-induced tumor and normal mucosa responses differ significantly according to fractionation schedule, with more mucosa injury observed in HYPO. Pathological responses of mucosa are also influenced by time-interval radiotherapy-surgery.
Octreotide prescribing patterns in the palliation of symptomatic inoperable malignant bowel obstruction patients at a single U.S. academic hospital.
Authors: Roeland Eric , Hwang Michael 
Published: February 2017

563 Background: Medical management is the cornerstone of malignant bowel obstruction (MBO) therapy and includes antisecretory agents such as octreotide. Currently, little data exist regarding octreotide prescribing patterns in U.S. academic hospitals in the palliation of inoperable MBO. Methods: This retrospective chart review evaluated inpatient with inoperable MBO receiving octretodie at a single academic US hospital (2008-2011). The prescribing primary service (medical vs. surgical), days to initiation of octreotide, daily dose, cumulative dose, length of stay (LOS), and overall survival (OS) were analyzed. Multiple linear regression was used to assess if the association between dose and LOS was significant. Kaplan-Meier curves and log rank test were used to evaluate OS. Results: A total of 767 patients received octreotide. 134 had diagnosis of cancer, and 37 (24 female, 13 male; mean age 56.7 years) had a confirmed inoperable MBO. The mean LOS was equivalent on both services (17 days). The mean octreotide dose was 201.2-μg medical vs. 119-μg surgical. Mean time to initiation was 8.4 days (7.9 medical vs. 8.8 surgical). Earlier initiation was associated with a shorter LOS (Spearman’s correlation= 0.76, p<0.0001). No statistically significant association was demonstrated between OS octreotide dose. Conclusions: Early initiation of octreotide may lead to shorter LOS; the association remains after adjustment for patient age. Timing and dose of octreotide use was not significantly associated with survival.
Correlation of bone marrow micrometastases (BMM) with nodal status in gastrointestinal tumors (GI).
Authors: Saha Sukamal , Korant Alpesh , Krishnamoorthy Madhumitha , Kanaan Mohammed Nawaf , Abadeer Benjamin , Arora Madan L. , Singh T. Trevor , Nagpal Sunil , Wiese David 
Published: February 2017

567 Background: Presence of BMM is an important prognostic factor for patients (pts) with solid tumors. Sentinel lymph node (SLN) mapping (M) has been found to upstage pts with GI tumors. However, a direct correlation between the presence of BMM and nodal metastases is lacking. Hence, a retrospective study was undertaken to determine the relationship between BMM and nodal status in GI tumors. Methods: A total of 385 consecutive pts with GI tumors were analyzed. All pts underwent bilateral posterior superior iliac spine BM aspiration. This protocol employs highly sensitive staining methods combined with automated microscopy to differentiate cytokeratin +ve cells of epithelial origin from normal hematopoetic cells in BM. The cytospin slides were stained with the monoclonal anti-CAM 5.2 antibody from Becton Dickinson at a 1:25 dilution. Visualization was achieved with Ventana view Red detection system. The slides were counterstained with Ventana haematoxylin. The Automated Cellular Imaging System is applied to detect, count, and classify cells of clinical interest based upon the recognition of cellular objects of particular color, size and shape. SLNM when applicable was done by peritumoral injection of 1% methylene blue. Results: Of these 385 pts, 11.2% were found to have BMM. When analyzed by sites, the 3 highest BMM were Cholangiocarcinoma 33%, Stomach 22% and esophagus 13%. The BMM was +ve bilaterally in 44%; unilaterally in 56%. In pts who underwent SLNM, BMM were found in 8.3% of SLN +ve vs. 12% for SLN -ve pts. For pts with colon cancer undergoing SLNM, BMM were found in 9.6% of SLN +ve pts vs. 11.1% for SLN -ve pts. Conclusions: BMM did not correlate with nodal status for GI malignancies suggesting a possible different mechanism for metastases. Detection of BMM may have a significant clinical value in SLN negative pts who may benefit from adjuvant therapy. [Table: see text]
Evaluation of the pathologic features of positive lymph nodes in the mesorectum after short-term preoperative chemoradiotherapy.
Authors: Beppu Naohito , Yanagi Hidenori , Doi Hiroshi , Kamikonya Norihiko , Inoue Yasuhiro , Tomita Naohiro , Yamanaka Naoki 
Published: February 2017

571 Background: The purpose of this study was to investigate the relationship between the pathological degeneration of primary tumor and positive lymph nodes (LNs) after preoperative chemoradiotherapy for rectal cancer. Methods: We analyzed the resected specimens from 53 patients (pts) with ypN+ rectal cancer received curative resection after chemoradiotherapy (25 Gy/10 fr/5 days+S-1 80 mg/m2×10 days).The primary tumor regression was assessed using the tumor regression grade (TRG 0 to 4) according to Dworak classification. 144 positive LNs in the mesorectum were measured and were assessed using the LN regression grade (LRG) as follows; LRG 1 =minor to moderate regression, LRG 2 =major regression, and LRG 3 =total regression. To confirm apoptosis, the LNs with LRG 2 or 3 were stained by TUNEL method. Furthermore, we examined the relationship among the size of LNs, the TRG, and the LRG. Results: The TRG 1, 2, and 3 was found in 24 pts, 15 pts, and 14 pts, respectively. In addition, there were no pts with TRG 0 or 4. The LRG 1, 2, and 3 was found in 74 LNs, 48 LNs, and 22 LNs, respectively. 14 in 15 LNs equal to or greater than 10 mm (≥10mm) showed the LRG 1.Whereas, in 129 LNs less than 10 mm (<10mm), the proportion of the LRG 2 or 3 in pts with each TRG was 33.8 % (26/77), 69.0 % (20/29), and 100 % (23/23) in the TRG 1, 2, and 3 respectively. Conclusions: 1) Larger LNs (≥10 mm) seemed to be radioresistant. 2) A good correlation of the response to chemoradiation between the primary tumor and LNs were observed in smaller LNs (< 10 mm). 3) Primary tumor with the TRG 3 can predict the efficacy of preoperative chemoradiotherapy for the positive LNs in the pts with rectal cancer.
Comparison of toxicity, efficacy, and dose modifications in obese and non-obese patients receiving modified FOLFOX6 (mFOLFOX) for metastatic colorectal cancer (mCRC).
Authors: Wojenski Daniel Jerzy , Finnes Heidi D. , Dierkhising Ross A. , McCullough Kristen Beth , Alberts Steven R. 
Published: February 2017

572 Background: There is limited data regarding chemotherapy dosing in obese mCRC patients. Methods: A retrospective, single institution, cohort study of mCRC patients receiving mFOLFOX6 (fluorouracil (5-FU) bolus omitted) was conducted between January 2002 and January 2011. Patients were stratified into: obese (BMI > 30) full dose, obese dose reduced (oxaliplatin (OX) and/or 5-FU), non-obese (BMI 18-29.9) full dose, and non-obese dose reduced. The primary endpoint was incidence of grade 3/4 myelosuppression within the first 12 wks of therapy. Secondary endpoints included incidence of any grade diarrhea and neuropathy, progression free (PFS) and overall survival (OS). Results: Of the 236 patients (72 obese, 164 non-obese), 15 obese and 37 non-obese received a dose reduction. Grade 3/4 myelosuppression occurred in 0 obese OX dose reduced, 3 (7.5%) obese full dose, 1 (8.3%) non-obese dose reduced, and 7 (7.8%) non-obese full dose patients (p=0.93). Grade 3/4 myelosuppression occurred in 0 obese 5-FU dose reduced, 3 (7.5%) obese full dose, 2 (12.5%) non-obese dose reduced, and 6 (7%) non-obese full dose patients (p=0.8). There were no statistically significant differences in the incidence of neuropathy or diarrhea between groups. PFS was longer in OX full dose patients (obese dose reduced, 8.8 mos; obese full dose, 10 mos; non-obese dose reduced, 3.7 mos; non-obese full dose, 10.4 mos; p=0.0094). No difference in PFS was found with 5-FU dosing (p=0.0615). OS favored OX full dose patients (obese dose reduced, 1.6 yrs; obese full dose, 2.4 yrs; non-obese dose reduced, 0.7 yrs; non-obese full dose, 2 yrs; p=0.0006) and 5-FU full dose patients (obese dose reduced, 1.6 yrs; obese full dose, 2.2 yrs; non-obese dose reduced, 1.6 yrs; non-obese full dose, 1.9 yrs; p=0.0287). Conclusions: There is no difference in the incidence of grade 3/4 myelosuppression, diarrhea or neuropathy in obese versus non-obese patients, dose reduced or not. OX dose reductions were associated with reduced PFS and OS. 5-FU dose reductions were associated with reduced OS. Our study supports ASCO recommendations against dose reductions in obese patients receiving chemotherapy.
A prospective study of XELOX plus bevacizumab as first-line therapy in Japanese patients with metastatic colorectal cancer (KSCC0902).
Authors: Takeuchi Masaaki , Ogata Yutaka , Tanaka Takaho , Kaibara Atsushi , Emi Yasunori , Saeki Hiroshi , Oki Eiji , Sadanaga Noriaki , Kusumoto Tetsuya , Touyama Tetsuo , Matsushita Hiroo , Shimokawa Mototugu , Baba Hideo , Shirouzu Kazuo , Maehara Yoshihiko ,   Kyushu Study Group of Clinical Cancer
Published: February 2017

583 Background: XELOX plus bevacizumab (Bev) is one of the standard therapies for metastatic colorectal cancer (mCRC). However there was no clinical practice date in Japan. This study was designed to evaluate the efficacy and safety of XELOX plus Bev in the clinical practice in Japanese mCRC patients (pts) including the elderly. Methods: The study design was multicenter, single-arm, open-label prospective study. The major inclusion criteria were previously untreated mCRC; presence of measurable lesions; age 20 years; ECOG performance status (PS) 0–2; and adequate organ function. Pts received Bev 7.5 mg/kg d1 and XELOX (oxaliplatin 130 mg/m2 d1 plus capecitabine 1,000 mg/m2 bid d1-14) q3w. This schedule was repeated until unacceptable toxicity or disease progression occurred. The primary endpoint was RECIST-confirmed objective response rate (ORR). A sample size of 41 was planned for a threshold ORR of 30% and expected value of 50%, with one-sided alpha of 0.05 and beta of approximately 0.2. Results: Of the 47 pts (male/female, 29/18; median age, 66 years (range 38-81); PS 0/1/2, 40/5/2) enrolled from May 2010 to Mar 2011. One patient did not fulfill the eligibility criteria. 46 pts were assessed for response; CR 1 pts, PR 23 pts, SD 15 pts, PD 2 pts, and NE 5 pts. The confirmed ORR was 52.2% (90% CI, 39.2-65.0%). The response rate across all time points without confirmation was 67.4% (95% CI, 52.0-80.5%). Median PFS and OS have not yet been reached. The most common grade 3/4 adverse events were anorexia 12.8%, neutropenia 10.6%, fatigue 8.5%, hypertension 4.3%, thrombocytopenia 4.3%, hand-foot syndrome 2.1% and bleeding 2.1%. Grade 3/4 peripheral neuropathy did not occur. Conclusions: First-line treatment of XELOX + Bev showed a promising response rate and an acceptable tolerability profile in the clinical practice in Japanese mCRC pts including the elderly. Clinical trial information: UMIN000003915.
Final results of RTOG 0246: A phase II study of selective surgical resection for locoregionally advanced esophageal cancer treated with a paclitaxel-based chemoradiation regimen.
Authors: Swisher Stephen , Moughan Jennifer , Komaki Ritsuko , Ajani Jaffer A. , Wu Tsung-Teh , Hofstetter Wayne Lewis , Konski Andre A. , Willett Christopher 
Published: February 2017

7 Background: The organ preserving strategy of selective esophageal resection after definitive chemoradiation was evaluated in a multi-center, prospective Phase II trial. Methods: Treatment involved induction chemotherapy with 5-FU (650 mg/mg2/d), cisplatin (15 mg/mg2/d) and paclitaxel (200 mg/mg2/d) for 2 cycles followed by concurrent chemoradiation with 50.4 Gy (1.8 Gy/fx) and daily 5-FU (300 mg/mg2/d) with cisplatin (15 mg/mg2/d) over the first 5 days. Following definitive chemoradiation, pts were evaluated for residual locoregional disease with chest and abdominal CT scans, EUS and optional PET scans. If there was no suspected residual disease patients were observed and monitored serially for recurrent disease at 3 mos x 2, 6 mos x 3 and then yrly. Esophageal resection was considered only for pts with suspected residual or recurrent locoregional esophageal cancer that did not have systemic disease. Results: 43 pts from Sept 2003 to March 2006 with non-metastatic resectable esophageal cancer were entered from 19 sites to RTOG 0246. 41 pts were eligible for analysis. 29 pts (73%) were adenocarcinoma histology with pretreatment clinical stage T3 or greater in 31 pts (76%) and N1 in 29 pts (71%). Following induction chemotherapy and chemoradiation 3 pts (7.3%) died of treatment related deaths and 1 pt died of disease progression. 21 pts (51%) underwent surgical resection following chemoradiation because of suspected residual disease 17 pts (41%), pt choice (1) or recurrent locoregional disease 3 pts (7%). 1 pt died postoperatively from esophageal anastomotic leak. 11 pts (27%) are alive and free of disease 70 to 90 months after chemoradiation, of which 5 (12%) did not have esophagectomy. With a median follow-up of 6.7 yrs (for 16 alive pts), the estimated overall 2.5 and 5-year survival rates (95% CI) are 46.3% (30.7%-60.6%) and 36.6% (22.3%-51.0%). Conclusions: The long-term results from this multi-center, prospective Phase II trial demonstrates the efficacy of a selective surgical resection approach following definitive chemoradiation in a predominantly adenocarcinoma population of locoregionally advanced esophageal cancer. Clinical trial information: NCT00081289.
Comparative outcomes of oncologic therapy in gastric extranodal marginal zone (MALT) lymphoma: Analysis of the Surveillance, Epidemiology and End Results (SEER)-Medicare database.
Authors: Olszewski Adam J. 
Published: February 2017

75 Background: Therapy for H. pylori (HPy)-negative or recurrent gastric MALT lymphoma is largely based on single-arm trials. The aim of this observational study was to compare outcomes after surgery, radiation (XRT) or chemotherapy (CT) in the SEER-Medicare dataset. Methods: Gastric MALT lymphoma cases diagnosed between 1997 and 2007 were selected, excluding patients without adequate Medicare coverage at diagnosis or follow up. Outcomes of XRT and CT were compared in stage IE group balanced by a propensity score. Flexible parametric models were used to study overall (OS) and lymphoma-specific survival (LSS). Treatments were evaluated with competing risk models, reporting hazard ratios (HR) and 95% confidence intervals (95%CI). Results: Among 1134 patients (median age: 77 years, median follow-up data: 4.3 years), 50% had no recorded oncologic treatment, 5% underwent surgery, 21% XRT and 24% CT as initial therapy, at a median of 3.4 months from diagnosis. HPyinfection was recorded in 19%. Oncologic therapy was more frequent in patients who were younger, diagnosed after 2000, with stage >IE and no poor performance status (PS) indicator. Worse LSS was associated with increasing age, male sex, poor PS, gastrointestinal hemorrhage/perforation, stage >IE, B-symptoms, being widowed or prior malignancy. In the 347 stage IE patients who received XRT or CT within 2 years of diagnosis, XRT alone as initial therapy was associated with better CSS than CT (HR 0.27, 95%CI 0.13-0.55, P<0.001). OS did not differ. Among the 321 patients treated with CT, 45% received rituximab (R) alone, 43% cyclophosphamide-based and 10% fludarabine-based regimens. The median OS after CT was 5.8 years without significant difference between these groups. Compared with patients receiving R alone, LSS was worse for those treated with CT alone (HR=2.31, 95%CI 1.2-4.26, P=.007), but did not significantly differ for those treated with R+CT (HR=1.63, 95%CI 0.84-31.17, P=0.15). Conclusions: XRT may be a preferable choice in elderly patients with stage IE gastric MALT lymphoma. In those requiring CT, addition of CT to rituximab alone is not associated with improved LSS.
Association of trimodality therapy (TMT) with rate of local-regional relapse and rare luminal-only relapse for patients with esophageal and esophagogastric junction (E-EGJ) cancer: Implications for the surveillance strategy.
Authors: Sudo Kazuki , Taketa Takashi , Correa Arlene M. , Campagna Maria-Claudia , Wadhwa Roopma , Blum Mariela A. , Komaki Ritsuko , Lee Jeffrey H. , Bhutani Manoop S. , Weston Brian , Liao Zhongxing X. , Rice David C. , Swisher Stephen , Hofstetter Wayne Lewis , Ajani Jaffer A. 
Published: February 2017

79 Background: For local-regional E-EGJ cancer patients, the preferred therapy is chemoradiation (CTRT) followed by surgery (TMT). Following TMT, esophagogastroduodenoscopy (EGD) and imaging studies are routinely performed but the literature lacks guidance for an evidence-based surveillance strategy. Methods: Between 2000 and 2010, 579 patients with local-regional E-EGJ cancer underwent TMT. We reviewed the patterns of relapse over time. Local-regional relapse was classified as regional or luminal-only. Overall survival was estimated by the Kaplan-Meier method. Results: For 579 patients, the median follow-up time was 57.4 months (95% confidence interval [CI]: 51.5-63.3 months). First relapses were as follows: 199 patients (34.4%) with distant metastases and 33 (5.7%) with local-regional relapse (of these only 10 [or 1.7% of 579] had a luminal-only relapse). 3 out of 33 patients underwent salvage surgery and survived >2 years from relapse. Sixteen out of 33 patients received CTRT and only 4 survived >2 years. Therefore, 7 (21% of patients with local-regional relapse or 1.2% of 579 patients) survived >2 years. For the 33 patients with local-regional relapse, the median overall survival from relapse was 15.3 months (95% CI: 11.0-19.6). Conclusions: After TMT therapy, local-regional relapses are uncommon (<6%) and luminal-only relapses are even rare (<2%). 91% of local-regional relapses occur within 3 years of surgery. Only 7 (1.2% of 579) patients survived > 2 years despite therapy. These data can contribute to an evidence-based surveillance strategy for E-EGJ cancer patients after TMT. Supported by UTMDACC and generous donors.