tbuckley/cabot-search huggingface dataset:
Understanding primary care provider (PCP) experiences with survivorship care plans (SCPs) and informational needs when caring for cancer survivors.
Authors: Natalie Garces, Tara Eaton, Myra M Robinson, Beth York, Chasse Margot Bailey-Dorton, Wendy G. Brick
Journal: Journal of Clinical Oncology (2017)

98 Background: Survivorship advocate organizations, including the Commission on Cancer and the American College of Surgeons, have proposed SCPs as one solution to help meet the post-treatment needs of cancer survivors and improve coordination of care between provider types. Though there have been a few recent studies investigating PCP evaluation of SCPs and their survivorship informational needs, widespread incorporation of PCP and other provider types’ perspectives on survivorship care planning and SCPs is lacking. Methods: Levine Cancer Institute emailed 598 surveys to PCPs and obstetrics and gynecology (OBGYN) providers affiliated with Carolinas HealthCare System. 159 surveys were returned (26.6% response rate) between February and August 2016. Results: Nearly half of providers reported having received a SCP (42.4%, 67 of 158) and the vast majority of those who did (95.5%, 64 of 67) found them useful. Providers stated that the most useful parts of the SCP for their practice needs were the surveillance recommendations (50.0%) and the treatment summary (45.3%). Respondents indicated the most challenging part of caring for cancer survivors is knowing the recommended surveillance tests/schedule/who is the responsible provider to order tests (53.8%) and knowing what late-effects of treatment to look out for (20.2%). The majority (77.7%) of providers reported using Up-to-Date to guide them in their care of patients who have completed cancer treatment. Providers indicated that guidelines for identifying and managing late (44.9%) and lingering (32.7%) effects of treatment would be the most helpful resources in caring for cancer survivors. Finally, providers reported interest in attending future CME conferences on surveillance (73.4%), managing late (57.8%) and lingering (54.1%) effects, and integrative and alternative therapies (24.8%). Conclusions: Preliminary findings from this internal survey suggest PCPs and OBGYNs may find SCPs useful and may need additional resources to guide their care of cancer survivors. We recommend formal study of preferences for SCP content among these understudied provider groups in the coordination of survivorship care.
Infectious complications associated with alemtuzumab treatment
Authors: S. A. Siddique, N. Fowler, E. Asatiani, B. Mavromatis, P. Cohen, C. M. Kessler, B. D. Cheson
Journal: Journal of Clinical Oncology (2007)

13504 Introduction: We report our single institutional experience of ICs associated with alemtuzumab treatment. Methods: Patients (pts) who received alemtuzumab were identified by review of the GUH pharmacy database. All ICs occurring from initiation of alemtuzumab until death or end of follow up as of January 3, 2007 were reviewed and categorized as opportunistic (OI) or non- opportunistic (NOIs). Pts who received hematopoetic stem cell or solid organ transplantation subsequent to alemtuzumab (n=33) or who could not tolerate test doses of alemtuzumab (n=1) were excluded from analysis. Results: Data were reviewed for 16 pts treated with alemtuzumab from February 2003 to September 2006. Median age was 60 years (range 40–78); with 4 females and 12 males. Fifteen pts had chronic lymphocytic leukemia (CLL), and 1 had acute lymphoblastic leukemia (ALL). Median follow-up after starting alemtuzumab treatment was 462 days. Pts with CLL had an average of 2.4 prior treatments (range 1–6). The pt with ALL received alemtuzumab as part of multi-agent intensification chemotherapy regimen. Alemtuzumab was administered subcutaneously, 30 mg three times a week. Median of 29 doses (range 7- 45) were given. Among CLL pts there was 1CR, 8 PRs and 6 PDs (RR 60%). Pneumocystis jirovenci (PCP) and herpersvirus (HSV) prophylaxis was given to 15 (93%) pts. Cytomegalovirus (CMV) surveillance was performed for all. Absolute lymphocyte count (ALC) &lt;1000/μL developed within 5 weeks in 12 (75%) pts. Median ALC at 8 weeks was 155/μL (range 0–18,612). Thirteen OIs were diagnosed in 9 (56%) pts including asymptomatic CMV viremia (n=5), PCP (n=2, one pt did not received PCP prophylaxis), invasive pulmonary aspergillosis (n=2), disseminated histoplasmosis (n=1), localized HSV (n=1), disseminated herpes zoster (n=1), and cerebral acanthamebiasis (n=1). Seven NOIs were noted in 6 pts including bacterial pneumonia, sinusitis, endocarditis and pseudo-membranous colitis. Mortality secondary to ICs was 31%. There was no correlation between ICs and age, duration of lymphoproliferative disorder, number of prior treatments, cumulative dose, response to alemtuzumab, or ALC. Conclusion: Despite adequate prophylaxis, ICs secondary to alemtuzumab are more frequent and diverse than previously reported in clinical trials. No significant financial relationships to disclose.
Effect of very small tumor size on recurrence-free survival and breast cancer-specific mortality stratified by guideline adherence: An analysis of the BRENDA Study Group.
Authors: Achim Wöckel, Lukas Schwentner, Manfred Wischnewsky, Rolf Kreienberg, Regine Wolters
Journal: Journal of Clinical Oncology (2013)

1096 Background: Small tumor size (&lt;5mm, T1a) carry an excellent prognosis, despite a variety of treatment approaches. Controversy exists over the extent of treatment, as to whether less than conventional treatment can be done. We therefore sought to explore the effect of very small tumor size on RFS and BCSM stratified by guideline adherence. Methods: The multicenter study population included 8935 early breast cancer patients diagnosed between 1992-2008, where 614 patients (6.9%) were T1a. T1a-patients were categorized according to guideline adherence and the influence on survival was calculated by Cox proportional hazard analyses (adjusted for age, grading, nodal status, hormonal status and co-existing morbidity). Results: The median age was 61 years and the median follow-up was 55 months. 449 [73.1%] patients were postmenopausal. 13.1% had G1, 61.9% G2 and 25% G3. 81.9% were HR positive and 18.4% HER2/neu-positive. 77.1% were N0, 11.9% had 1-3 and 11% more than 3 affected lymph nodes. Only 262 (42.7%) pts. were guideline adherent. Compared to guideline adherent patients RFS and BCSM were significantly (p&lt; 0.001) worse for guideline-non-adherent patients (RFS: HR=3.88; 95% C.I.: 1.91-7.87) and (BCSM: HR= 4.28; 95% C.I.:2.04-9.00). After adjusting for age, grading, nodal status, hormone receptor status and comorbidity guideline adherence was still the most important variable for RFS and BCSM (RFS: p&lt;0.001; HR=3.71; 95%C.I.: 1.80-7.67) and (BCSM: p&lt;0.001; HR=3.82; 95% C.I.:1.80-8.11).The most important impact on RFS and BCSM had guideline violations of radiation (RFS: p=0.001; HR=3.19;95%C.I.:1.66-6.13) and (BCSM: p=0.009;HR=2.42;95%C.I.:124-4.72) respectively of chemotherapy (RFS: p=0.001;HR=1.43; 95%C.I.:1.43-4.39) and (BCSM: p&lt;0.001;HR=3.17;95%C.I.:1.84-5.46). Conclusions: There is a strong association between guideline adherence and improved recurrence free survival and reduced breast cancer-specific mortality for breast cancer patients with very small tumor size. Violation of treatment guidelines for postoperative irradiation or chemotherapy is clearly associated with a deterioration of prognosis.
Phase I dose-finding study of golvatinib (E7050), a c-Met and Eph receptor targeted multi-kinase inhibitor, administered orally BID to patients with advanced solid tumors.
Authors: Toshihiko Doi, Takayuki Yoshino, Nozomu Fuse, Hideaki Bando, Makoto Tahara, Masahiro Ohki, Katsuki Fujino, Yuki Nishioka, Kentaro Matsuura, Takashi Sawada, Atsushi Ohtsu
Journal: Journal of Clinical Oncology (2012)

3079 Background: Golvatinib is a highly potent, small molecule ATP-competitive inhibitor of the c-Met receptor tyrosine kinase and multiple members of the Eph receptor family as well as c-Kit and Ron, based on isolated kinase assays. Golvatinib showed antiproliferative activity in human cancer xenograft models, warranting further investigation in the clinical setting. Methods: Japanese patients (pts) with advanced solid tumors that had progressed after approved therapy received oral golvatinib at escalating doses of 50 to 100, 200 and 300 mg administered twice daily (BID) in conventional 3 pt cohorts. The primary objective was to determine the MTD of golvatinib when administered continually BID. The secondary objectives were to evaluate the safety, PK, PD biomarkers, and efficacy. Results: 16pts were enrolled (8 M, 8 F; med age 59 years; ECOG 0-1). Tumor types were colorectal (5), gastric (4) and others (7). One DLT (Gr 3 ALT increase) and 1 equivalent DLT (Gr 2 vomiting, nausea and anorexia) appeared in 2 pts in the 300 mg BID cohort and the dose escalation was terminated. The MTD was determined to be 200 mg BID. Frequently observed adverse drug reactions were proteinuria [50.0% (8/16)], ALT increased [43.8% (7/16)], AST increased, nausea, vomiting [37.5% (6/16)], and blood alkaline phosphatase increased, decreased appetite, diarrhea, leukopenia [31.3% (5/16)], which were all mild to moderate in severity with ≤ Gr 2. No related severe adverse event was observed. Responses included 4 stable diseases (84-113 days) in 3 pts with gastric cancer and 1 patient with NSCLC, 11 progressive diseases, and 1 non evaluable. The golvatinib plasma concentration after first-dose reached C max at a median time of 2 to 4 hours, and declined bi-exponentially with a t ½ of approximately 40 hours. C max and AUC 0-inf increased with dose. Analysis of blood PD biomarker showed a significant increase in soluble c-Met levels after golvatinib treatment. Conclusions: The MTD of golvatinib was achieved at 200 mg BID. Golvatinib was well tolerated with manageable toxicities at dose levels up to and including the MTD. 4 of 16 pts showed stable disease after golvatinib treatment.
DOCOX: A phase II trial with docetaxel and oxaliplatin as a second-line systemic therapy for patients with advanced and/or metastatic adenocarcinoma of the pancreas.
Authors: Thomas Jens Ettrich, Goetz von Wichert, Thomas M. Gress, Patrick Michl, Michael Geissler, Holger Frithjof Hebart, Andreas W. Berger, Marc Porzner, Bettina Danner, Rainer Muche, Thomas Seufferlein
Journal: Journal of Clinical Oncology (2013)

4034 Background: In Europe and the USA, pancreatic ductal adenocarcinoma (PDAC) is the fifth most common cause of cancer-related death. For patients with metastatic disease, palliative cytostatic systemic treatment is the only option. There is no established standard for 2 nd -line treatment. Fluoropyrimidines either alone or in combination with Oxaliplatin or other chemotherapeutic agents are increasingly used. There are interesting data regarding the combination of Gemcitabine with Oxaliplatin or Docetaxel with respect to progression free survival (PFS) and tumor response in 1 st -line. For the first time, the DocOx-trial investigates the combination of Oxaliplatin with Docetaxel as 2 nd -line treatment after progression under palliative first-line systemic treatment with Gemcitabine. Methods: Prospective, single arm, non-randomized, multicenter, Simon´s two stage phase II trial using Docetaxel (75 mg/m 2 , 60 min, d 1) plus Oxaliplatin (80 mg/m 2 , 120 min, d 2, qd 22). Duration of the trial is scheduled up to 8 cycles. Primary endpoint: tumor response (RR) according to RECIST 1.0. Secondary endpoints: PFS, OS, safety/toxicity, QoL/clinical benefit. Results: Here we present the data on response rate (RR), median progression free survival (mPFS) and median overall survival (mOS) as of February 4th, 2013. Data represents the Intention to treat-analysis of the 44 patients included between 2009 and 2012. 5 patients did not obtain any treatment. RR was 16% (7 partial remissions, no complete remission) with a disease control rate (DCR) of 48% after the first two treatment cycles. Median PFS was 7 weeks ( 95%-CI: 6-16 w.) and median OS after start of 2 nd -line therapy was 36 weeks ( 95%-CI: 19-55 w.). Conclusions: In this single-arm 2 nd -line trial for the treatment of PDAC, the combination of Doxcetaxel and Oxaliplatin shows very promising results compared to other 2 nd -line-protocols such as OFF. Some patients seem to benefit particularly as indicated by long periods of treatment in this setting. Even after 8 cycles of treatment with DocOx, partial response was observed in 2 patients and stable disease in another 6 patients corresponding a disease control rate of 18%. Clinical trial information: NCT00690300.
Drug-induced liver injury: recent advances in diagnosis and risk assessment
Authors: Gerd A Kullak-Ublick, Raul J Andrade, Michael Merz, Peter End, Andreas Benesic, Alexander L Gerbes, Guruprasad P Aithal
Journal: Gut (2017)

Idiosyncratic drug-induced liver injury (IDILI) is a rare but potentially severe adverse drug reaction that should be considered in patients who develop laboratory criteria for liver injury secondary to the administration of a potentially hepatotoxic drug. Although currently used liver parameters are sensitive in detecting DILI, they are neither specific nor able to predict the patient9s subsequent clinical course. Genetic risk assessment is useful mainly due to its high negative predictive value, with several human leucocyte antigen alleles being associated with DILI. New emerging biomarkers which could be useful in assessing DILI include total keratin18 (K18) and caspase-cleaved keratin18 (ccK18), macrophage colony-stimulating factor receptor 1, high mobility group box 1 and microRNA-122. From the numerous in vitro test systems that are available, monocyte-derived hepatocytes generated from patients with DILI show promise in identifying the DILI-causing agent from among a panel of coprescribed drugs. Several computer-based algorithms are available that rely on cumulative scores of known risk factors such as the administered dose or potential liabilities such as mitochondrial toxicity, inhibition of the bile salt export pump or the formation of reactive metabolites. A novel DILI cluster score is being developed which predicts DILI from multiple complimentary cluster and classification models using absorption–distribution–metabolism–elimination-related as well as physicochemical properties, diverse substructural descriptors and known structural liabilities. The provision of more advanced scientific and regulatory guidance for liver safety assessment will depend on validating the new diagnostic markers in the ongoing DILI registries, biobanks and public–private partnerships.
Impact of erlotinib activity on overall survival in non small cell lung cancer patients: Is the post progression survival a new paradigm?
Authors: Tindara Franchina, Alessandro Russo, Claudia Proto, Giuseppe Chiofalo, Maria Picciotto, Antonino Scimone, Giuseppe Toscano, Rosa Berenato, Laura Noto, Vincenzo Adamo
Journal: Journal of Clinical Oncology (2013)

e19086 Background: In the last few years, the treatment of non-small cell lung cancer (NSCLC) has been dramatically changed with the introduction of EGFR TK (Epidermal Growth Factor Tyrosine Kinase) inhibitors. Given its objectivity and the benefits derived by patients, overall survival (OS) has been historically considered the most important therapeutic objective in advanced NSCLC. However, little is known about postprogression survival (PPS) in NSCLC. This study evaluates the correlation between response to erlotinib and post progression survival (i.e. the time between disease progression and death) to estimate the impact of this drug on overall survival. Methods: We retrospectively analyzed 68 NSCLC unselected patients consecutively treated with second or third line erlotinib at our institution from 2007 to 2010, including in the responder group patients who progressed after stable disease on erlotinib for at least six months (n=20). The relationship between OS and PPS was evaluated by standard statistical tests. P-values &lt;0.05 were considered statistically significant. Results: Survival was significantly prolonged in responders patients (18.6 vs 11.3) suggesting the important role of EGFR TK inhibitors in NSCLC management. In addition a significant increase of PPS was recorded in these patients (9.1 vs 4.6 p=0.02), allowing to perform further therapy lines to better control cancer evolution. Conclusions: These data underline the key role of EGFR in NSCLC growth and progression and the impact of erlotinib in cancer control evolution. Post progression therapy influence the effect on overall survival. This analysis suggests that a treatment strategy incorporating all active agents over the course of disease optimizes OS. Further investigations will be needed in selected patients harboring EGFR-activating mutations to better define the role of PPS as new indicator of erlotinib efficacy.
Chemotherapy for metastatic colon cancer: Effect on survival when the dose is reduced due to side effects.
Authors: Stefan Munker, Michael Gerken, Petra Fest, Claudia Ott, Elisabeth Schnoy, Stefan Fichtner-Feigl, Philipp Wiggermann, Martin Vogelhuber, Wolfgang Herr, Chrisitan Stroszczynski, Hans J. Schlitt, Matthias Evert, Michael Reng, Monika Klinikhammer-Schalke, Andreas Teufel
Journal: Journal of Clinical Oncology (2017)

761 Background: 5-Fluorouracil (5FU), Folinic acid (FA), and Oxaliplatin (FOLFOX) or 5FU, FA, and Irinotecan (FOLFIRI) are standard regimens for palliative chemotherapy of metastatic colon cancer. Since data showing the influence of dose reduction in palliative treatment are rare, the objective of this single center, retrospective study was to further characterize the influence of dose reduction on efficacy of these therapeutic regimens. Methods: 109 patients, diagnosed with stage IV colon cancer between 2004 and 2012 and receiving palliative first-line chemotherapy with either FOLFOX or FOLFIRI regimens in our outpatient clinic were analyzed for treatment efficacy. Patients who received dose reductions due to side effects usually received doses of 80% or lower of per protocol dose. Survival data were obtained from the Regensburg Tumor Registry. Survival analysis was performed using Kaplan-Meier statistical analysis. Results: Dose reduction was independent of age. Major reasons for dose reduction were neutropenia (30%) followed by polyneuropathy (16%) and diarrhea (14%). Dosage was more often reduced in patients receiving FOLFOX based therapy. Two-year survival of FOLFOX and FOLFIRI treated patients was comparable (35%). We observed no significant (p = 0.323) difference on two-year survival in patients receiving a reduction of chemotherapy with dose reduction (48%) compared to standard dose (31%). Further subgroup analysis did not reveal any subgroup of patients suffering from side effects with significantly worse outcome upon dose reduction. In contrast, patients who underwent dose reduction received more cycles of chemotherapy (13.7 vs. 10.8 cycles) and cumulative dosage was similar in both groups. Conclusions: A moderate reduction of chemotherapy due to side effects has no measurable effect on survival in patients with palliative colorectal cancer. This may be partially due to a longer treatment of patients with reduced chemotherapy dosage if side effects are present.
Burden of metastatic hormone-sensitive prostate cancer to identify men more likely to benefit from early docetaxel.
Authors: Gwenaelle Gravis, Jean-Marie Boher, Yu-Hui Chen, Glenn Liu, Karim Fizazi, Michael Anthony Carducci, Stephane Oudard, Florence Joly, David Frazier Jarrard, Michel Soulie, Mario A. Eisenberger, Muriel Habibian, Robert Dreicer, Jorge A. Garcia, Maha Hussain, Manish Kohli, Nicholas J. Vogelzang, Joel Picus, Robert S. DiPaola, Christopher Sweeney
Journal: Journal of Clinical Oncology (2017)

136 Background: Patients with a low burden of metastatic disease and who relapse after localized therapy with curative intent have a longer overall survival. It is unclear whether these patients benefit from early docetaxel (D). Methods: Patients in GETUG-AFU15 (N = 385, median follow-up 84 mo) and CHAARTED (N = 790, median follow up 54 mo) were randomized to ADT alone or ADT + D and outcomes described using the same definition of high volume (HV) and low volume (LV) disease. (HV: visceral metastases and/or 4 or more bone metastases with at least one outside the axis) and whether the patients had prior local therapy or not. Results: Table 1 details across both studies that de novo HV group treated with ADT alone has the shortest overall survival and D has a consistent effect in improving OS. In contrast, in both studies patients with LV disease had a much longer OS with no evidence that D improved OS. Conclusions: There was no apparent survival benefit in CHAARTED and GETUG-15 studies with D for LV whether patients had prior local treatment or not. Across both studies, early D had a consistent effect and improved OS in HV pts especially those with no prior local therapy. Partial Support and drug supply by Sanofi. Clinical trial information: NCT00104715, NCT00309985. [Table: see text]
Email communication practices and preferences among patients and providers in a large comprehensive cancer center.
Authors: Natalie Cook, Aditi Dobriyal, Manjula Maganti, Michal Sheinis, Alice Chia-chi Wei, Jolie Ringash, Monika K. Krzyzanowska
Journal: Journal of Clinical Oncology (2015)

6519 Background: Little is known about how email is currently used in healthcare to facilitate patient care. The objective of our study was to understand current practices and preferences of patients (pts) and physicians (MDs) for email communication. Methods: Separate cross-sectional surveys were administered to pts and MDs (staff physicians and clinical fellows) at Princess Margaret Cancer Center. Survey domains included current email and internet use practices, digital literacy skills, perceived barriers and preferences regarding email use to facilitate care. Logistic regression was used to identify factors associated with current email use. Chart review was conducted to assess the impact of email communication on care. Results: The survey was completed by 833 pts, of which 50% reported previous email contact with a healthcare professional (HCP) including administrative assistants (52%), MDs (51%: 36% with specialist; 18% with primary care; 3% both) and nurses (45%). Most pts (87%) were satisfied with this method of communication. Patient factors associated with higher likelihood of email contact with a HCP included younger age (p<0.0001), higher education (p<0.0001) and higher income (p<0.0001). Enrollment in clinical trials (p<0.0001), receipt of multiple treatments (p=0.001) and receipt of chemotherapy (p=0.0006) were also associated with higher likelihood of email contact. Pts had less concerns about using email for health care if they had prior email contact with HCPs compared to those with no prior email contact (60% vs. 70%; p=0.004). Of the 80 MDs who responded to the survey (response rate 30%), 80% had previous contact with a pt via email although only 24% felt this should be used regularly to communicate with pts. All MDs reported email contact with other HCPs about pt related matters and all felt this to be an effective way to communicate. 962 pt charts were reviewed with email correspondence documented in 9% of cases. Conclusions: Email is commonly used for pt care but poorly documented and there may be a mismatch between pt/MD preferences. The use of email in this setting can be developed with appropriate guidance, however there may be concerns about widening the gap for certain groups of pts.