bluuebunny/crossref_metadata_2025_split huggingface dataset:
A phase II study of preoperative chemotherapy with S-1 (S) and cisplatin (P) followed by D3 gastrectomy for gastric cancer (GC) with extensive lymph node metastasis (ELM): Survival results of JCOG0405.
Authors: Yoshikawa T. , Nakamura K. , Tsuburaya A. , Sano T. , Mizusawa J. , Katai H. , Kurita A. , Uyama I. , Nomura E. , Sasako M. ,   Gastric Cancer Surgical Study Group of Japan Clinical Oncology Group
Published: February 2017

70 Background: GC with ELM, especially in case of M1(LYM), is regarded unresectable in many countries, while challenge is ongoing in Japan to treat them by intensive chemotherapy followed by super extended surgery. In our previous phase II study (JCOG0001) for the same population, iritotecan plus P (IP) chemotherapy followed by surgery showed remarkable survival of 27.0% at 3 years but its toxicity led to rather high treatment related death (TRD). Development of safer and more effective treatment is urged. Methods: Eligibility criteria included histologically proven gastric adenocarcinoma; bulky nodal involvement around major branched arteries to the stomach and/or para-aortic nodal metastases; cM0 (except para-aortic nodes); negative lavage cytology; not linitis plastica type; PS of 0 or 1. Patients (pts) received two or three 28- day cycles of induction chemotherapy of S (80 mg/m2 from day 1 to 21) and P (60 mg/m2 on day 8), and then underwent D3 gastrectomy. Primary endpoint was R0 resection and key secondary endpoint was 3-year survival. Other secondary endpoints included response rate and adverse events. Results: Between 02/2005 and 06/2007, 53 pts were enrolled and 2 pts were ineligible. Only surrogate endpoints of efficacy and feasibility were reported in ASCO-GI 2008, which included clinical response of 64.7%, R0 of 82.4%, pathological response of 51.0%, and no TRD with low toxicities. The 3-year overall survival, which we first clarified in this report, was 58.8% (95% CI, 44.1-70.9%). Conclusions: Preoperative SP followed by D3 gastrectomy demonstrated excellent 3-year survival with low mortality compared with preoperative IP, which was far better result than expected against this unresectable population. This multimodal treatment is highly promising for GC with ELM. [Table: see text]
Randomized controlled trial of omental bursectomy for resectable cT2-3 gastric cancer.
Authors: Kurokawa Y. , Fujiwara Y. , Takiguchi S. , Fujita J. , Imamura H. , Tsujinaka T. , Mori M. , Doki Y. 
Published: February 2017

72 Background: Omental bursectomy, a traditional surgical procedure to dissect the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon, has often been performed against resectable gastric cancer. We have conducted a multi- institutional randomized controlled trial to elucidate the safety and usefulness of this procedure. Methods: Patients with cT2 or cT3 gastric adenocarcinoma were intraoperatively randomized to radical gastrectomy plus D2 lymphadenectomy either with or without bursectomy. The primary endpoint was overall survival (OS). The planned sample size was 464, with an alpha error of 0.05 and statistical power of 80% to detect a 10% margin of non-inferiority for the non-bursectomy group. The first interim analysis was conducted on Sep 2008, and we decided the preliminary data release according to Korn's proposal (J Clin Oncol. 2005). Results: Between Jul 2002 and Jan 2007, a total of 210 patients were randomized to either the bursectomy group or the non-bursectomy group. Background characteristics were well balanced. Intraoperative blood loss was greater in the bursectomy group than in the non-bursectomy group (median, 475 mL vs. 350 mL, p=0.047), while other surgical factors did not vary significantly. The overall morbidity rate was 14%, the same between two groups. The hospital mortality rate was 0.95%; one patient per group. In the first interim analysis, the 3-year OS were 86% in bursectomy group and 79% in non-bursectomy group, and the hazard ratio was 1.55 (95% CI: 0.84-2.84). The non-bursectomy group had more patients with peritoneal recurrences than the bursectomy group (14% vs. 8%). Conclusions: Experienced surgeons could safely perform a D2 gastrectomy with an additional bursectomy. First interim analysis suggested the survival advantage of omental bursectomy for cT2-3 gastric cancer patients. Final analysis will be conducted in 2012. No significant financial relationships to disclose.
Outcomes of chemoradiotherapy with a high irradiation dose using a 3D radiation treatment planning system for esophageal cancer.
Authors: Murakami Y. , Nagata Y. , Nishibuchi I. , Kimura T. , Kenjo M. , Kaneyasu Y. 
Published: February 2017

89 Background: The standard irradiation dose of chemoradiotherapy (CRT) for esophageal cancer is 50.4 Gy, however, the trials in which this standard dose was originated were based on 2D radiation treatment planning. In this study we assessed the survival and toxicities of CRT with a dose of 60-66 Gy using a 3D radiation treatment planning system (3DRTPS) for esophageal cancer. Methods: One hundred and two eligible patients with esophageal cancer treated by definitive CRT between 2000 and 2006 were assessed. Median age was 67 years old. There were stage I in 22 patients, stage II-III (without T4) in 27 and T4/M1Lymph legions in 53. There were 100 patients with squamous cell carcinoma histology and 2 with small cell carcinoma. Main tumor sites were cervical/upper/middle/lower thoracic in 15/19/43/25 patients. Treatment planning of irradiation was performed using a CT based 3DRTPS. Total irradiation dose of our protocol was 60-66 Gy. Accomplishment rate of planned irradiation was 93%. All patients received chemotherapy concurrently with radiotherapy. Fluorouracil based chemotherapy was performed in 96 patients (94%). Results: The data was updated in August 2010. The median follow-up was 67 months. Cause-specific survival rates at 5 years for stage I, II-III (without T4) and T4/M1lymph were 100%, 49% and 17%, respectively and overall survival rates were 66%, 35% and 13%, respectively. Complete response (CR) rates were 100%, 79% and 35%, respectively and failure rates of CR cases were 5%, 43% and 42%, respectively. Late adverse effects (≥ grade 3) were observed in 11 patients (10%); pneumonitis in 4 (4%), pleural effusion in 4 (4%) and pericardial effusion in 5 (5%). Treatment related deaths were observed in 2 cases (pneumonitis developed during treatment in 1 and debility due to treatment in 1). Conclusions: Toxicities of CRT with a high irradiation dose using 3DRTPS for esophageal cancer were acceptable and survival was promising. Dose intensification study of 50.4 Gy versus ≥ 60 Gy in CRT using a 3D-conformal radiation therapy technique for esophageal cancer should be considered. No significant financial relationships to disclose.
Epirubicin (E) in combination with cisplatin (CDDP) and capecitabine (C) versus docetaxel (D) combined with 5-fluorouracil (5-FU) by continuous infusion as front-line therapy in patients with advanced gastric cancer (AGC): Preliminary results of a randomized phase II trial of the Gruppo Oncologico Dell'Italia Meridionale.
Authors: Maiello E. , De Vita F. , Gebbia V. , Lorusso V. , Cinieri S. , Giuliani F. , Orditura M. , Fistola E. , Filippelli G. , Colucci G. 
Published: February 2017

97 Background: Combination chemotherapy regimens improve outcome of AGC patients even if there is no accepted global standard regimen. Compared with ECF, D in combination with 5-FU c.i. shown promising efficacy in a phase II randomised study (J Clin Oncol. 23:494;2005). REAL-2 trial demonstrated that C was effective as 5-FU c.i. when used as part of a triple combination regimen turning the treatment into an easier to administer regimen (N Engl J Med. 358: 36; 2008). In the present study we compare DF versus ECX as first-line therapy of AGC. Methods: Patients with previously untreated histologically documented AGC, with at least one measurable disease, age < 18 years, ECOG PS ≤ 2, and age 18-75 years, were randomly assigned to receive E (50 mg/m2 day 1), CDDP (60 mg/m2 day 1) and C (625 mg/m2 bid, days 1-21) (ECX) or D (85 mg/m2 day 1) and 5-FU (750 mg/m2/day c.i., days 1-5) (DF) q 3 weeks. RECIST and NCI criteria were employed to determine the activity and the toxicity of these regimens. Results: The main characteristics in ECX and DF arms were: M/F = 22/14 and 23/8, median age = 58 years (range 39-74 years) and 61 years (range 44-75 years), site of disease = liver in 29 (82.8%) and in 20 (64.5%) patients, lung in 7 (20%) and in 4 (12.9%) patients, lymph-nodes in 26 (74.2%) and in 21 (67.7%) patients, multiple 14 (20%) versus 21 (60%) and 16 (51.6%) versus 14 (48.4%). ORR (CR + PR) was 54.3% in ECX arm and 22.6% in DF arm. Nine PRO were observed in both arms (25.7% and 29.2%, respectively). Main toxicity rate (G3-4) in the evaluable patients assigned to ECX arm were neutropenia (28.5% versus 19.4%), nausea/vomiting (18.2% versus 3.2%), alopecia (22.8% versus 18.3%) and H&F syndrome (5.7% versus 0%). The worst toxicity (G3-4) in DF arm was anaemia (9.6% versus 5.7%). Conclusions: Preliminary results of this study shown an higher ORR of ECX regimen with respect to DF with a favourable toxicity profile. No significant financial relationships to disclose.
Single-institution experience of preoperative chemoradiotherapy for locally advanced gastric cancer.
Authors: Pepek J. M. , Chino J. P. , Willett C. G. , Tyler D. S. , Uronis H. E. , Czito B. G. 
Published: February 2017

99 Background: To examine acute toxicity and outcomes for patients treated with preoperative chemoradiotherapy (CRT) for gastric cancer. Methods: Patients with gastroesophageal (GE) junction (Siewert type II and III) or stomach adenocarcinoma who underwent curative intent CRT followed by planned surgical resection at Duke University between 1987 and 2009 were reviewed. Tumors were staged according to AJCC 6th edition. Local recurrence was defined as radiographic or biopsy- proven disease within the radiation treatment field. Overall survival (OS), local control (LC) and disease-free survival (DFS) were estimated using the Kaplan-Meier method. Toxicity was graded according to CTCAE v4.0. Results: Forty-eight patients (60% stage III, 8% stage IV) were included. Most (73%) had proximal (GE junction, cardia and fundus) tumors. Thirty-five percent had signet ring histology, 52% had poorly differentiated tumors and 10% had linitis plastica. Median age was 60 years and median RT dose was 45 Gy. All patients received concurrent chemotherapy (CT) with 40 (83%) receiving 5-FU-based CT. Rates of acute > grade 2 hematologic and non-hematologic toxicity were 38% and 10%, respectively. Six patients (13%) required treatment break and two (4%) were unable to complete the prescribed treatment course. Thirty-six patients (75%) underwent surgery. Patients did not undergo surgery due to distant metastases at laparotomy or restaging (n=9), patient refusal (n=2) or poor performance status (n=1). Pathologic complete response and R0 resection rates were 19% and 86%, respectively. Thirty-day surgical mortality was 6%. At 42 months median follow-up, 3-year actuarial OS for all patients was 40%. For those undergoing surgery, 3-year OS, LC and DFS were 50%, 73% and 41%, respectively. Conclusions: Preoperative CRT for gastric cancer is reasonably well tolerated with acceptable rates of perioperative morbidity and mortality. In this patient cohort with advanced disease, LC, DFS and OS rates in resected patients are comparable to similarly staged, adjuvantly treated historic controls. Further study comparing neoadjuvant CRT to standard treatment approaches for gastric cancer is indicated. No significant financial relationships to disclose.
Safety of proton therapy treatment for prostate cancer patients with unilateral hip replacements.
Authors: Nichols R. C. , Hoppe B. S. , Ho M. W. , Martinez H. , Henderson R. H. , Marcus R. , Mendenhall W. M. , Costa J. A. , Williams C. R. , Mendenhall N. P. 
Published: February 2017

100 Background: Determine the feasibility of proton therapy for prostate cancer patients who have undergone unilateral hip replacement. Methods: From January, 2007 to March, 2008 5 patients with localized (4) or locally recurrent (1) prostate cancer and previous unilateral hip replacement underwent hip avoiding proton therapy. The median target dose was 78 Cobalt Gray Equivalent (Range 74CGE to 82CGE). All patients were treated in the supine position without a rectal balloon. Median maximum (1cc) dose to the normal femoral head was 51.47CGE (Range 43.82CGE to 64.50CGE). All patients signed informed consent and were registered to either the IRB approved UFPTI PR01, PR02 or Outcome Tracking (OTP) Protocols. Results: With a median follow up of 28 (range 15 to 39) months, no patient experienced grade 2 or higher late rectal toxicity. No patient experienced grade 3 or higher late urinary toxicity. Two patients experienced grade 2 urinary toxicity by virtue of having been placed on medication (tamsulosin) for urinary obstructive symptoms. No patient has reported hip fracture, hip pain or other skeletal event in the normal hip. Conclusions: Our experience suggests that patients with unilateral hip replacements can be treated with hip avoiding proton therapy without an increased risk of urinary, rectal or skeletal complications. No significant financial relationships to disclose.
A multi-institutional study of 3,794 patients undergoing robotic-assisted laparoscopic radical prostatectomy to determine the surgical learning curve for positive margins and operating time.
Authors: Sooriakumaran P. , John M. , Leung R. , Peters D. , Lee D. , Wiklund P. , Tewari A. 
Published: February 2017

102 Background: The surgical learning curve for robotic assisted laparoscopic radical prostatectomy (RALP) is often cited as being shorter than for other surgical modalities. However, while this appears true with regards to surgical safety, the learning curve for more refined variables like positive surgical margin (PSM) rate and operative time (OT) is not well established. Our objective was to assess the surgical learning curve for RALP in terms of these parameters. Methods: We performed a retrospective cohort study of 3,794 patients who underwent RALP between Jan 2003 and Sep 2009 by three surgeons (DL, PW, AKT) from three centers (UPenn, Karolinska, Cornell). Mean overall PSM rates and mean overall OT were calculated for all three surgeons at intervals of 50 RALPs per surgeon, and learning curves for these means were fit using a loess method. R version 2.71 was used for all statistical analysis. Results: The learning curve for PSM rates for all patients demonstrated improvements that continued with greater surgeon experience, with over 1,600 cases required to get a PSM rate <10%. When only pT3 patients were evaluated, the learning curve started to plateau after 1,000-1,500 cases. Mean OT plateaued after 750 cases although with further surgical experience the OTs started to climb again. Conclusions: The learning curve for RALP is not as short as previously thought, and a large number of cases are needed to get PSM rates and OTs to a minimum. This suggests that RALP should be performed by high volume surgeons in order to optimize patient outcomes. [Table: see text]
Outcomes of patients with clinical lymphadenopathy treated with radical prostatectomy.
Authors: Higuchi T. T. , Breau R. H. , Umbreit E. C. , Bergstralh E. J. , Rangel L. J. , Carlson R. , Karnes R. J. 
Published: February 2017

106 Background: Some patients with lymph node metastases experience prolonged survival following radical prostatectomy. The purpose of this study was to determine the outcome of patients with clinically suspicious lymph nodes on preoperative imaging who underwent radical prostatectomy and lymphadenectomy. Methods: Patients with lymph node metastases diagnosed during radical prostatectomy from 1988-2003 were reviewed. Patients with preoperative CT or MRI images were included in the study. Radiology reports were reviewed to determine if patients had clinically suspicious lymphadenopathy (cN+). For all analyses, patients with cN+ were compared to those with clinically negative nodes (cN−). Results: Preoperative imaging was available in 202 men with lymph node metastasis at the time of prostatectomy. Of these 17% (34/202) were cN+. None had pre-operative lymph node biopsy and none had abandoned prostatectomy. At a median follow-up of 11.1 years, PSA recurrence occurred in 50% (17/34) and 49% (82/186), local recurrence in 18% (6/34) and 13% (22/186) and systemic progression in 32% (11/34) and 24% (40/186) of patients with cN+ and cN-, respectively. On multivariate analysis, cN+ was not associated with increased risk of death (HR 1.66, p=0.1). Conclusions: cN+ patients undergoing surgical therapy for prostate cancer may experience similar outcomes to cN− patients. The presence of clinically suspicious lymph nodes on preoperative imaging should not be an absolute contraindication for surgical therapy. No significant financial relationships to disclose.
Radical prostatectomy (RP) in extreme ages: Clinical and pathologic evaluation of localized prostate cancer (PC).
Authors: Dettino A. A. , Fonseca F. P. , Zequi S. C. , Sacomani C. A. , Rinck J. , Formiga N. , Lopes A. 
Published: February 2017

109 Background: Radical prostatectomy (RP) is the treatment of choice for patients with localized prostate cancer (PC). Previously, surgery was applied to patients with good clinical condition and aged <=70 years. Lately, with a better understanding of surgical technique, many centers have been performing RP in patients older than 70. Methods: The main objective of this cohort study is to evaluate clinical evolution according to localized PC submitted to RP in patients in extreme ages. We analysed age, PSA, ASA classification,pathological stages, Gleason scores, urinary continence, D'Amico risk classification (group 1:low; 2:intermediate; 3:high), biochemical recurrence and clinical progression. Descriptive analysis of the population was performed. Fisher's exact test or chi-square tests were used to evaluate association between clinicopathologic characteristics.Biochemical recurrence was defined by PSA more than 0.2 ng/mL post-RP. Results: In 262 patients, mean age was 63.4 years (SD 12.4; range: 41 to 83). In D'Amico's group 1 there were 96 patients (37.2%) with<=50 year old, and group 2 had 162 patients (62.8%) with age >=70. The mean follow-up in group 1 was 55.9 months (SD 41.7) and group 2 was 53.6 (SD 41.4), p=0.6770. Biochemical relapse occurred in 21 patients (15.44%) in D'Amico risk group 1, 27 (36.99%) in group 2 and 29 (59.18%) in group 3 (p<0.001). There was no difference among all the pathological variables evaluated (p>0.05). Clinical progression occurred in 2 patients (1.47%) in D'Amico risk group 1, in 3 patients (4.11%) in group 2 and in 3 patients (6.11%) in group 3 (p=0.230). There was no significant difference in relation to time to biochemical recurrence, as well as biochemical relapse rate and progression of this disease among the groups. Younger patients (in group 1) recovered earlier from urinary incontinence, as well as most were continent in final follow-up. Conclusions: Based on our results, the differences in younger or more aged patients with PC are not related to pathological variables, or rates of biochemical recurrence and clinical disease, but better preoperative clinical features and better recovery of urinary continence are seen in younger patients. No significant financial relationships to disclose.
A phase II study of pomegranate extract for men with rising prostate-specific antigen following primary therapy.
Authors: Carducci M. A. , Paller C. J. , Wozniak P. , Sieber P. , Greengold R. , Stockton B. , Hertzman B. , Roper R. , Liker H. , Ye X. ,   The Pom Wonderful Working Group
Published: February 2017

11 Background: Pomegranate extract (POMx) demonstrates promising antitumor effects in prostate cancer (PCA). Prior published work reveals an increase in PSA doubling time (PSADT) in a single arm study of pomegranate juice (POM) in PCA patients (pts) with a rising PSA after local therapy. We sought to determine the effects of low (1 gram) or high (3 grams) daily POMx on PSADT in a similar but broader population of men seeking to defer androgen deprivation therapy. Methods: Our multi-center, double bind phase II trial randomized men with rising PSA and without metastases to receive high or low dose POMx, stratified by baseline PSADT and Gleason score, and with no restrictions for PSADT and no upper limit PSA value. Men were treated until progression or for 18 months. PSA levels were obtained every 3 months. This study was designed to detect a 6 month increase in PSADT from baseline. Results: 104 patients were enrolled and treated for up to 6 (92%), 12 (70%) and 18 months (36%). Median PSADT lengthened in the Intent to treat population (96% white, median age 74.5 years, median Gleason score 7) from baseline 11.9 (range 1.6-54.6) compared to 18.5 (2-1523) months after treatment (p<.001).There was no significant treatment difference on PSADT between the dose groups (p=.920). Declining PSA levels were observed in 13 pts (13%) during the study. No significant changes occurred in testosterone in either group. Although no clinically significant toxicities were seen, mild to moderate diarrhea was seen in 8 pts (7.7%). Conclusions: POMx treatment significantly increased the PSADT by over 6 months in both treatment arms, with no effect on testosterone. This IND-conducted study confirms slowing of PSADT after treatment with POMx as was found with POM, yet in a PCA patient population with greater high risk progression features. [Table: see text]
Cabazitaxel or mitoxantrone with prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel: Estimating mean overall survival (OS) for health economic analyses from a phase III trial (TROPIC).
Authors: Oudard S. , Joulain F. , De Geer A. , Sartor A. O. 
Published: February 2017

128^ Background: TROPIC evaluated the efficacy and safety of the novel taxane cabazitaxel in men with mCRPC previously treated with docetaxel. Median OS was significantly improved, as previously reported (12.7 months in mitoxantrone arm vs 15.1 months in cabazitaxel arm, HR=0.72 [0.61 – 0.84], p<0.0001- updated OS results). Median OS is the most useful descriptive statistic for physicians and patients as it reflects a point estimate in time by which 50% patients may survive regardless of disease status or progression. It avoids assumptions on long-term survival beyond the follow-up period of the clinical trial. Payers however are interested in making a coverage and reimbursement decisions based on the overall therapeutic benefit relative to its risk, and the expected impact on healthcare expenditures. Analyses such as cost-effectiveness analysis therefore require the estimation of mean OS. Methods: Mean OS is only observable when the last patient has died. Its estimation can be derived via an extrapolation of the trial Kaplan-Meier curve using a survival function. Several parametric distributions (exponential, weibull, lognormal, loglogistic and Gompertz) were tested. The parametric distribution that best fitted the trial Kaplan-Meier curves was selected using the Akaike's Information criteria (AIC), the Bayesian Information Criteria (BIC) and graphical method to evaluate the goodness of fit of the distributions. Mean OS from the best fitted model was generated to support payer decision making. Results: Using AIC/BIC and graphical method, the Weibull survival function, S(t)=exp(-l ts) where l is a scale parameter and s a shape parameter, was selected as the distribution that best fitted the TROPIC data. Results of the estimated mean survival assuming a Weibull function are described in the table. Conclusions: Assuming a Weibull distribution, mean OS is estimated at 14.5 months in mitoxantrone arm vs 18.5 months in cabazitaxel arm, leading to 4 months OS difference in favour of cabazitaxel. [Table: see text] [Table: see text]