tbuckley/cabot-search huggingface dataset:
The efficacy of oxaliplatin-based adjuvant chemotherapy for stage IV colorectal cancer after R0 resection.
Authors: Izuma Nakayama, Mitsukuni Suenaga, Takeru Wakatsuki, Mariko Ogura, Masato Ozaka, Eiji Shinozaki, Satoshi Matsusaka, Keisho Chin, Nobuyuki Mizunuma, Toshiharu Yamaguchi
Journal: Journal of Clinical Oncology (2014)

638 Background: In previous phase III studies (MOSAIC and XELOXA trial), oxaliplatin based chemotherapy was shown to be a standard adjuvant treatment for stage III colorectal cancer (CRC). However, its efficacy for curatively resected stage IV CRC has not yet been clarified. In this retrospective study, we evaluate the efficacy of oxaliplatin based chemotherapy in adjuvant setting for curatively resected stage IV CRC. Methods: Eighty-three patients received adjuvant chemotherapy after R0 resection for Stage IV CRC in our institute between Mar 2007 and Feb 2013. Progression-free survival (PFS), overall survival (OS), completion rate of the treatment and safety were evaluated. Median follow-up time was 33.3 months. Results: Baseline characteristics were as follows (N=83): median age, 61; male/female, 46/37; ECOG PS0, all; colon/rectum, 54/29; synchronous/asynchronous, 41/42. Metastatic sites were liver in 46, lung in 11, peritoneum in 13, lymph node in 12 patients. Median PFS and OS were not reached. Three-year PFS and OS were 67.8% and 88.2%, respectively. Completion rate was 78.6% of the patients. In univariate analysis, completion of treatment, synchronous development and metastasis limited to lung were associated with better PFS, though not statistically significant. Confirmed regional lymph node metastasis of primary tumor showed a trend toward to concern with poor OS. Differences in metastatic site were not observed in both PFS and OS. Multivariate analysis revealed none as a significant prognostic factor. Conclusions: Compared the results to previous trial for stage III CRC, oxaliplatin based adjuvant chemotherapy for stage IV CRC after R0 resection was demonstrated to be consistent in tolerability and efficacy.
Cost-effectiveness analysis of first-line treatment for metastatic renal cell carcinoma (mRCC) in Colombia (ONCOLGroup study)
Authors: J. Godoy, A. F. Cardona, H. Cáceres, J. M. Otero, M. Lujan, D. Lopera, J. O. Pacheco, A. Spath, P. Gis
Journal: Journal of Clinical Oncology (2009)

e16150 Background: Renal cell carcinoma has increased its incidence by 126% since 1950. A local study developed a complete economic evaluation of sunitinib versus IFN in first-line treatment of mRCC in Colombia, finding that sunitinib was more cost-useful and cost-effective. Methods: A Markov model was developed using 6-week cycles for evaluating the cost-effectiveness of four interventions (IFN, sunitinib, bevacizumab+IFN, sorafenib) approved as first-line treatment for mRCC in Colombia. The model used the third-party payer perspective and a 5-year time-line; it also presumed that all the patients (pts) continued with active treatment until progression when it became acceptable to continue with a second-line treatment or BSC. Overall survival (OS) and progression-free survival (PFS) curves of IFN were used as reference framework; they were obtained form a published clinical trial. The hazard ratios (HR) for PFS and OS were estimated for comparing new generation medicaments with IFN. The information about frequency of use and health service cost units consumed in Colombia was taken from a series of 24 pts treated in Manizales, Pereira, Medellín and Bogotá. Service costs were requested from an external consultant and corresponded to the average value billed by the EPSs, calculated from 33 sources of information which were representative of the country's market. The cost of the medicaments was obtained from LCLC. The costs and benefits were discounted annually at 3%. (all cost are presented in Colombian pesos Col$ 2008 with an exchange rate 1 USD = 1836.20 Col$). Results: Incremental analysis indicated a difference of 41.1 million Col$ in the average total cost of treatment when Sunitinib was compared to IFN; in contrast, comparing sorafenib and Bevacizumab+INF to sunitinib demonstrated that the average total cost was less for the sunitinib by 8.3 and 104.2 million Col$, respectively. Additionally, the ratios of incremental cost-effectiveness by life years (LY) gained demonstrated sunitinib's simple dominance over sorafenib and the combination of bevacizumab+IFN, and an average by LY gained of 100.5 million Col$ compared to IFN. Conclusions: Sunitinib is the most cost-effective option as first-line treatment for mRCC pts in Colombia. [Table: see text]
Clinical implication of peritoneal cytology in the pancreatic cancer patients who underwent curative resection followed by adjuvant gemcitabine or s-1 chemotherapy.
Authors: Yusuke Katayama, Toru Aoyama, Masaaki Murakawa, Masahiro Asari, Koichiro Yamaoku, Amane Kanazawa, Akio Higuchi, Manabu Shiozawa, Makoto Ueno, Manabu Morimoto, Makoto Akaike, Takashi Oshima, Yasushi Rino, Munetaka Masuda, Soichiro Morinaga
Journal: Journal of Clinical Oncology (2015)

252 Background: The clinical implications of peritoneal lavage cytology (CY) status in the patients who received curative resection and adjuvant chemotherapy have not been established. The clinical implications of peritoneal lavage cytology (CY) status in the patients who received curative resection and adjuvant chemotherapy have not been established. Methods: We retrospectively analyzed clinical data from 143 consecutive patients who underwent macroscopically curative resection and received adjuvant gemcitabine or S-1 chemotherapy for pancreatic cancer from 2005 to 2014 in our institution. Correlations between CY status and survival and clinicopathological features were investigated. Results: Of the 143 patients, 21 patients were peritoneal washing cytology positive (CY+) (14.7%). Although significant difference was observed in the tumor size, no other correlation between cytology status and clinicopathological parameter existed (age, gender, histology, UICC T status, LN metastasis, lymphovascular invasion). The recurrence free survival (RFS) rates at 3 and 5 years after surgery were 5.1% and 0% in CY+ patients, respectively, and were 21.5% and 16.1% in peritoneal washing cytology negative (CY-) patients, respectively, which were significantly different (p&lt;0.001). On the other hands, the OS rates at 3 and 5 years after surgery were 17.1% and 8.6% in CY+ patients, respectively, and were 26.1% and 16.1% in CY- patients, respectively, which were trend to worse in the CY+ patients. However, there was not significantly different (p=0.254). Conclusions: The patients with CY+ are likely to experience recurrence, even after they received curative resection and adjuvant Gemcitabine or S-1adjuvant chemotherapy. To improve the patient’s survival, it is necessary to develop efficient treatment for CY+ patients.
Subjective and objective assessment of oxaliplatin-induced peripheral neuropathy.
Authors: Teppei Yamada, Yoichiro Yoshida, Naoya Aisu, Taisuke Matsuoka, Daibo Kojima, Syu Tanimura, Seiichiro Hoshino, Ai Mogi, Tomoko Koganemaru, Mayumi Oda, Mahiru Fukuda, Fumiaki Kiyomi, Keita Noda, Keiji Hirata, Kazuo Tamura, Yuichi Yamashita
Journal: Journal of Clinical Oncology (2015)

772 Background: Oxaliplatin-induced peripheral neuropathy (PN), for which no therapy has been firmly established, is a critical factor that makes the continuation of chemotherapy difficult. Numbness and pain are currently evaluated using subjective methods such as the visual analog scale (VAS). However, because the assessment of pain can greatly vary depending on the mood and physical state of the patient at the time of assessment, it is best to objectively evaluate pain. Therefore, a method for objective assessment is also required to evaluate drugs designed to ameliorate PN. Pain Vision PS-2100 (PV) is an analytical instrument that was designed to quantitatively and objectively assess sense perception and nociception in a patient. Although it is used in the field of anesthesiology, there have been no reports concerning its use for the assessment of oxaliplatin-induced PN. Methods: The present study examined the correlation of subjective and objective assessment results using VAS and PV, respectively, for cases of oxaliplatin-induced PN. Subjects comprised 58 patients with colorectal cancer who underwent chemotherapy at the Fukuoka University. Results: Both VAS and PV assessments of PN were performed 173 times in total, and partial correlation coefficient analysis adjusted by subject and gender. The VAS and PV mean values of PN were 20.5 (0–100) and 27.9 (0–416), respectively. The partial correlation coefficient was 0.258 (p=0.0053). Conclusions: Although both assessments evaluated the same events, no strong correlation was observed between the results and a weak correlation was observed between VAS and PV. These results suggest that because VAS and PV each measure different factors, both subjective and objective assessments of drugs designed to ameliorate oxaliplatin-induced PN are necessary.
Alternative sequencing of FOLFIRI or mFOLFOX6 with erlotinib in the second-line treatment of metastatic colorectal cancer (mCRC): An ongoing phase II trial.
Authors: Charles D. Lopez, Gina M. Vaccaro, Kerstin M Kampa-Schittenhelm, John M. Strother, Andrea Burt, Jeff Masterson
Journal: Journal of Clinical Oncology (2012)

507 Background: Despite 1 st -line response rates (RR) in mCRC of &gt; 50% with FOLFOX or FOLFIRI, 2 nd -line RRs are less (FOLFOX ~ 15%; FOLFIRI ~ 4%). Thus, there is a critical need for better 2 nd -line strategies. Although use of anti-EGFR antibodies with chemotherapy has validated EGFR as a target in wt-KRAS mCRC, combining anti-EGFR tyrosine-kinase-inhibitors (TKIs) with chemotherapy has not shown consistent activity/tolerability. In vitro, anti-EGFR TKIs can induce a G0/G1 cell cycle arrest that attenuates chemo-induced apoptosis. However, when we alternately sequenced chemotherapy with erlotinib in HCT116p53+/+ CRC cells (mut-KRAS), we found markedly enhanced apoptosis (compared to chemotherapy alone or concurrent chemo/erlotinib). Based on these results, we initiated a clinical trial to alternately sequence 2 nd -line chemotherapy with erlotinib in mCRC. Methods: Non-randomized, parallel Simon’s two-stage phase II (optimum design) using 2 nd -line (opposite of 1 st -line) mFOLFOX6 or FOLFIRI (d1,2; d14,15) alternating with erlotinib (E) 100 mgs qd (d3-8; d16-21). Primary objective: radiographic RRs by RECIST criteria. Secondary objectives: time to progression (TTP), 2 nd progression free survival (PFS), toxicity and tolerability. 1 st stage analysis at 10 pts/arm: mFOLFOX6/E or FOLFIRI/E arms will continue if &gt;2/10 pts, or &gt;1/10 pts, respectively with CR/PRs. 2 nd -stage analysis at 29 pts/arm: mFOLFOX6/E or FOLFIRI/E will be considered promising if &gt; 4/29 pts, or &gt; 6/29 pts, respectively demonstrate CR/PRs. Results: n=15 pts to date. Of evaluable pts: 2 PR, 4 SD, 3 PD were observed in the FOLFIRI/E arm (n=9) and 1 SD in mFOLFOX6/E arm (n=1). Gr3/4 toxicities (n=10 evaluable pts): neutropenia (7), rash (1), nausea (1), oral pain (1), diarrhea (1), elevated LFTs (1), hyponatremia (1), elevated INR (1), GI bleed (1), abd pain (1). Dose reductions/treatment delays in evaluable pts: FOLFIRI/E (n=4/9); mFOLFOX6/E (n=0/1). Conclusions: The FOLFIRI/E arm demonstrates sufficient responses to expand accrual into the 2 nd -stage. The mFOLFOX6/E arm continues 1 st -stage accrual. Toxicities were generally manageable. Molecular correlates are ongoing.
Comparing the Value of Serum Ferritin, Transfusion History and Magnetic Resonance Imaging for the Prediction of Iron Overload In MDS and AML Patients Undergoing Allogeneic Stem Cell Transplantation.
Authors: Martin Wermke, Jan Moritz Middeke, Nona Shayegi, Verena Plodeck, Michael Laniado, Gerhard Ehninger, Martin Bornhäuser, Uwe Platzbecker
Journal: Blood (2010)
Use of electronic medical record queries to support clinical decision quality assurance.
Authors: Michelle Nielsen, Senti Senthelal, Jidong Lian, Miller MacPherson, Gaylene Medlam, Tessa Larsen, Jonathan Tsao, John Radwan, Marisa Finlay, Jasper Yuen, Yongjin Wang, Sarah Rauth, Jonathan Fung Wan, Thomas McGowan
Journal: Journal of Clinical Oncology (2013)

239 Background: Clinical Treatment Decisions in radiation oncology direct the patient’s treatment plans. There is a need for Clinical Decisions to be peer reviewed preferably in real time before the patient plan is completed. Traditional peer review of clinical decisions which ensure high quality patient treatments can be challenging in a busy radiation oncology clinic. Leveraging Electronic Medical Records (EMR) to query standard patient staging and demographics data per disease type allows for efficient peer review of the clinical decision. Methods: Through the use of EMR system (Aria, Varian Medical Systems, Palo Alto CA), data is entered into the radiation oncology chart by the primary radiation oncologist during a patient’s work up. Tools within the EMR have been configured to automatically query patient charts and summarize the data. A second Oncologist runs the query, reviews the data and peer reviews clinical decision for radiotherapy including treatment intent, dose and target contours. The radiation oncologist can then discuss modifications with the original oncologist, or indicate to the dosimetrist to continue planning. Those clinical decisions that are uncertain are escalated to review in a traditional peer review setting. Results: The EMR queries have allowed a shift to real time peer review of clinical decisions. The summary of disease specific staging and demographics data has added to efficiency in clinic in both the oncologists’ ability to complete a timely peer review and the lowering the amount of planning rework. Traditional peer review setting is then used to discuss the controversial and complex cases that would receive the most benefit. Conclusions: The ability to leverage electronic medical record data has made the peer review of clinical decisions in our institution more efficient and therefore the majority can be completed in real time.
Outcomes of RCC patients with venous thrombus presenting with pulmonary embolism: A multicenter analysis of 782 consecutive patients.
Authors: Edwin Jason Abel, Christopher G. Wood, Patrick Kenney, Nathan Eickstaedt, Aditya Bagrodia, Daniel Ramirez, Bishoy A. Gayed, Ramy F. Youssef, Christopher Odom, Vitaly Margulis
Journal: Journal of Clinical Oncology (2013)

433 Background: Renal cell carcinoma (RCC) patients who present with pulmonary embolism (PE) and venous thrombus may not be offered surgery because of concerns with anti-coagulation and presumed poor post-surgical outcomes. The objective of this study was to evaluate post-surgical recurrence and disease specific survival (DSS) in RCC patients with venous thrombus who had PE diagnosed at initial presentation. Methods: After IRB approval, we reviewed the records from 2000-2011 at 3 tertiary hospitals (UW, UTMDACC, UTSW) for all consecutive RCC patients who had nephrectomy with thrombectomy. Clinical and pathologic predictive factors for recurrence and survival were collected for each patient. Univariate and multivariate analysis was used to evaluate whether PE at presentation was associated with RCC recurrence or DSS after nephrectomy with thrombectomy. Results: Preoperative PE was diagnosed in 35/782 (0.5%) RCC patients undergoing nephrectomy with thrombectomy with a median follow-up time of 22 months. Patients with PE at initial diagnosis were more likely to have higher level thrombus (p&lt;0.01) but no differences were found between groups for age, gender, race, tumor diameter, Fuhrman grade, sarcomatoid de-differentiation, peri-nephric fat invasion or histologic subtype. In N0M0 patients, there was no difference (p=0.36) in the rate of RCC recurrence for 395/782(50%) or 7/17(41%) patients without PE or with PE respectively. On multivariate analysis, peri-nephric fat invasion, Fuhrman grade, and thrombus height, but not preoperative PE status, were predictive of recurrence risk. Similarly, there was no difference in the rates of lung metastases for 67/123 (53%) N0M0 patients without PE or 3/7 (43%) patients with PE (p=0.71). Preoperative PE diagnosis was not predictive of death from RCC (p=0.58). On multivariate analysis, peri-nephric fat invasion, sarcomatoid de-differentiation, Fuhrman grade, and thrombus height, were independently predictive of risk of death from RCC. Conclusions: PE at initial diagnosis is not associated with worse post-surgical recurrence or survival in RCC patients with tumor thrombus.
Randomized clinical trial of the effect of simo decoction plus acupuncture and chewing gum on postoperative ileus in patients with hepatocellular carcinoma after hepatic resection.
Authors: Jian-Hong Zhong, Xue-Mei You, Liang Ma, Le-Qun Li
Journal: Journal of Clinical Oncology (2016)

307 Background: Postoperative ileus (POI) is a common complication following hepatic resection that delays recovery of bowel function and increases length of hospital stay. Simo decoction (SMD) and acupuncture tsusanli acupoint are used to enhance bowel hypomotility in China. Chewing gum reducing POI is reported. The aim of study is to evaluate the effect of SMD plus acupuncture tsusanli acupoint and chewing gum alone on POI and length of hospital stay in patients with hepatocellular carcinoma (HCC) after hepatic resection. Methods: Primary HCC patients undergoing hepatic resection were randomized to SMD plus acupuncture, chewing gum, or empty control group. Interventions were started on postoperative day 1 for six consecutive days or until flatus. Primary endpoints were POI and length of hospital stay. Secondary endpoints were surgical complications. Results: Between March 2015 and August 2015, 162 patients were randomized to SMD plus acupuncture (55), chewing gum (53), or empty control (54). SMD plus acupuncture or chewing gum group have significantly shorter first peristalsis, flatus, and defaecation time than empty control group (all P&lt; 0.05). The mean (s.d.) length of hospital stay of the three groups was 14.0 (4.9), 14.7 (6.2), and 16.5 (6.8) days. The difference between SMD plus acupuncture and empty control group was significant (P = 0.014). However, chewing gum cannot significantly shorten hospital stay than empty control (P = 0.147). Interventions groups had less grade I and II complications. Conclusions: SMD plus acupuncture or chewing gum is a safe treatment to reduce POI and shorten hospital stay. Registration number: NCT02438436 (https://clinicaltrials.gov). Clinical trial information: NCT02438436.
Resection of colorectal cancer (CRC) metastases in routine practice.
Authors: Ben Tran, Hui-li Wong, Kathryn Maree Field, Jeanne Tie, Jeremy David Shapiro, Rachel Wong, Desmond Yip, Louise M. Nott, Gary Edward Richardson, Joseph James McKendrick, Peter Gibbs
Journal: Journal of Clinical Oncology (2014)

599 Background: The optimal management of metastatic colorectal cancer (mCRC) involves a multimodality approach. Complete resection of limited metastatic disease is a critical, potentially curative intervention for a minority of patients (pts). Data on resection rates and outcomes in routine clinical practice are limited. Methods: Analysis of pts prospectively entered onto the TRACC (Treatment of Recurrent and Advanced Colorectal Cancer) database, a multisite Australian mCRC registry. Data collection commenced in July 2009 and is ongoing at 14 centres. Treatment intent was recorded at initial pt review as curative, potentially curative or palliative. Results: At median follow-up of 20.9 months, 213 (21%) of 1,012 pts have undergone metastasectomy, including 179 (84%) R0 resections. Liver (55.4%) and lung (20.2%) were the commonest resected disease sites. For 26 (12.2%) pts the initial treatment intent had been palliative. Pts who had metastases resected were younger (median age 63 vs. 70 years, p&lt;0.0001), of better performance status (PS0-1: 97.7 vs. 75.5%, p&lt;0.0001), had fewer comorbidities (Charlson Index ≤3: 75.1 vs. 55.9%, p&lt;0.0001) and fewer sites of disease (single site: 79.8% vs. 52.5%, p&lt;0.0001). A significantly higher proportion of pts treated in private than public hospitals underwent resections: 143/548 (26.1%) vs. 70/459 (15.3%), p&lt;0.0001. At initial presentation, more private pts had PS0-1 (82.8% vs. 77.8%, p=0.0459) and single disease site (61.3% vs. 54.5%, p=0.0291) than public pts, but the median age of private pts was higher (70 vs. 67 years, p=0.041). Overall survival was equivalent for resected pts in both groups (median not reached, HR 0.96, 95% CI 0.45-2.06, p=0.9189). Conclusions: A substantial proportion of mCRC pts in routine practice undergo resection of distant metastases, including some pts initially considered incurable. Significant variation between sites has been noted, which may relate to differences in pt population and/or a more aggressive treatment approach. Multivariate analyses and review of individual centre data are planned to explore reasons for potential underutilization of this critical intervention.
Radium-223 (Ra-223) re-treatment (Re-tx): First experience from an international, multicenter, prospective study in patients (Pts) with castration-resistant prostate cancer and bone metastases (mCRPC).
Authors: A. Oliver Sartor, Daniel Heinrich, Neil Mariados, María José Méndez-Vidal, Daniel Keizman, Camilla Thellenberg-Karlsson, Avivit Peer, Giuseppe Procopio, Stephen Jay Frank, Kalevi Pulkkanen, Stefano Severi, Jose Manuel Trigo Perez, Paul Schwarzenberger, Rui Li, Luke T. Nordquist
Journal: Journal of Clinical Oncology (2016)

197 Background: Ra-223 tx for up to 6 injections (inj) is indicated for pts with symptomatic bone metastases. Ra-223 tx beyond 6 inj has not been previously reported. Herein we report the first safety and efficacy findings of Ra-223 re-tx from an international prospective trial in mCRPC pts. Methods: Pts with CRPC with ≥ 2 bone mets who completed 6 initial Ra-223 inj with no disease progression in bone and progressed after initial tx were potentially eligible for Ra-223 re-tx, provided that hematologic (heme) parameters were adequate. No concomitant cytotoxic agents were allowed; other agents were allowed at investigator discretion. Primary objective was safety. Exploratory objectives were time to radiographic bone progression, time to ALP progression, and radiographic progression-free survival (rPFS) based on MRI/CT and bone scans performed q 3 mo. Results: 44 pts had Ra-223 re-tx, 29 (66%) completed tx with all 6 inj; median (med) number inj = 6. Med time from initial Ra-223 tx = 6 mo. Besides prior Ra-223, all pts had ≥ 2 hormonal regimens; 45% had ≥ 1 chemotherapy regimen. 32 (73%) failed novel hormonal agents, eg, abiraterone and enzalutamide. Baseline characteristics were comparable to ALSYMPCA (Table). No new safety concerns were noted; incidence of tx-emergent adverse events (TEAEs) in re-tx pts was comparable to or lower than ALSYMPCA (Table). Only 2 re-tx pts had grade 3 heme TEAEs. Only 1 pt had radiographic bone progression; med time to ALP progression was not reached. Med rPFS = 9.9 mo. Conclusions: Ra-223 re-tx was well tolerated in this highly selected population, with minimal heme toxicity, and provided continued control of disease progression in bone. Clinical trial information: NCT01934790. [Table: see text] [Table: see text]