tbuckley/cabot-search huggingface dataset:
Tumor response outcomes in first-line treatment of wild-type (WT) <i>RAS</i> metastatic colorectal carcinoma (mCRC) following modified FOLFOX6 (mFOLFOX6) + either panitumumab (pmab) or bevacizumab (bev).
Authors: Fernando Rivera, Meinolf Karthaus, J. Randolph Hecht, Gianpiero Fasola, Jean-Luc Canon, Reija Koukakis, Jan-Henrik Terwey, Lee Steven Schwartzberg
Journal: Journal of Clinical Oncology (2015)

3535 Background: In the PEAK study, pmab + mFOLFOX6 was associated with longer overall survival (OS) than bev + mFOLFOX6 in first-line RAS WT mCRC. RECIST overall response rates (ORR) were similar between treatment arms. Here, we report exploratory analyses of tumor assessments beyond RECIST. Methods: PEAK was a randomized phase 2 study of first-line pmab + mFOLFOX6 vs bev + mFOLFOX6 in previously untreated mCRC. ORRs (investigator assessed), median duration of response (DoR; from first confirmed response to disease progression or death [secondary endpoint]) and depth of response (DpR; defined as the percentage of tumor shrinkage at nadir or progression) in RAS WT patients (pts) were calculated by treatment. Early tumor shrinkage (ETS) was defined as the proportion of pts with ≥ 30% tumor shrinkage at week 8 (exploratory analysis). Results: Overall, 169 pts withRAS WT mCRC were included in the ORR analysis and 154 had tumor-shrinkage data available at baseline and week 8. Significantly more pts in the pmab + mFOLFOX6 arm had ETS at week 8 vs the bev + mFOLFOX6 arm (Table). ORRs were similar in the two arms, while DoR was significantly longer and DpR significantly greater with pmab + mFOLFOX6 (Table). ≥ 30% vs < 30% tumor shrinkage at week 8 was associated with longer median PFS (HR: 0.52 [95% CI: 0.29–0.92] and HR: 0.65 [95% CI: 0.38–1.13]) and OS (HR: 0.44 [95% CI: 0.15–1.32] and HR: 0.23 [95% CI: 0.08–0.66]) for pmab + mFOLFOX6 and bev + mFOLFOX6, respectively. Conclusions: Although ORR appeared to be similar or only numerically improved in the pmab arm of PEAK, the responses observed appeared to occur earlier, last longer and be deeper in our exploratory analyses. This is consistent with the observed OS and PFS benefit, and with data reported earlier from the FIRE3 study. Clinical trial information: NCT00819780. Pmab + mFOLFOX6 Bev + mFOLFOX6 p-value ORR (median [95% CI]), % 65 (54–75) 62 (50–72) – DoR (median [95% CI]), months 11.4 (9.7–13.6) 8.5 (6.3–9.3) 0.0142 ETS, % patients 64 45 0.0232 DpR (median [IQR]), % 65 (48–87) 46 (29–62) 0.0007 CI = confidence interval; IQR = interquartile range
Role of concurrent systemic chemotherapy and total parental nutrition (TPN) for the treatment of malignant small bowel obstruction (SBO).
Authors: Rohan Gupta, Jay Singh Chouhan, Joseph Ensor, David R. Fogelman, Daniel E. Epner, Robert A. Wolff, Michael Fisch, Michael J. Overman
Journal: Journal of Clinical Oncology (2015)

e20701 Background: The development of malignant SBO represents a poor prognosis event with limited therapeutic options. Surgical intervention for cases that fail conservative management is associated with high morbidity and mortality. Whether an aggressive approach involving concurrent TPN and systemic chemotherapy has a role in this setting is unknown. The aim of this study was to evaluate the clinical course of patients who receive concomitant TPN and systemic chemotherapy for persistent malignant SBO. Methods: The MD Anderson pharmacy database was queried for adult solid tumor pts who received concurrent TPN and intravenous chemotherapy from 2005-2013 (n = 212). 82 pts met the following inclusion criteria: documented non-duodenal SBO, TPN > = 10 days (definition for failed conservative management), and presence of peritoneal carcinomatosis. Results: 82 pts [62% female, median age 55 (17-85) yrs, tumor types (60% gastrointestinal, 22% gyneocological, 18% other)] were analyzed. Chemotherapy was 5-fluorouracil-based in 39%, taxane-based in 18%, and other in 42%. Median duration of TPN prior to chemotherapy was 8.5 days (1-87) and median duration of TPN was 56 days (10-665). ICU admissions, in hospital death and TPN related complications occurred in 28%, 24% and 33% pts respectively. A radiographic tumor response occurred in 19 (23%) pts. Median overall survival (OS) from the start of TPN and chemotherapy was 3.1 months (95% CI 2.6-5.2) and 1-year OS was 12.6%. In multivariate analysis, the duration of metastatic disease prior to SBO (p = 0.02) and radiographic response (p < 0.01) were significant. Pts with a radiographic response had a median OS of 8.1 months (95% CI 5.0-11.4) compared to 2.6 months (95% CI 1.8-3.7) in non-responders. SBO resolution occurred in 10 pts (12%) and only correlated with a radiographic response to chemotherapy (OR 6.4, 95% CI 1.6-24.9, p = 0.04). Conclusions: Systemic chemotherapy and TPN as a treatment approach for malignant SBO that fails conservative management demonstrates poor success in resolving an SBO and carries both a high morbidity and mortality. This treatment approach for malignant SBO should not represent a standard of care approach.
Phase 2 trial of GS-9973, a selective Syk inhibitor, in chronic lymphocytic leukemia (CLL).
Authors: Jeff Porter Sharman, Leonard M. Klein, Michael Boxer, Kathryn S. Kolibaba, Esteban Abella-Dominicis, Michael J. Hawkins, Julie Di Paolo, Jing Hu, Anita Reddy, Feng Jin, Flordeliza Melchor-Khan, Christopher A. Yasenchak
Journal: Journal of Clinical Oncology (2014)

7007 Background: Spleen tyrosine kinase (Syk) is a mediator of B-cell receptor signaling in normal and transformed B-cells. GS-9973 is an orally bioavailable, selective inhibitor of Syk (Kd 7.6 nM, no other kinase < 100 nM). Methods: This Phase 2 trial enrolled 44 subjects with CLL treated with GS-9973 800 mg BID. Tumor imaging occurred at weeks 8, 16, 24 and then every 12. Response was independently evaluated according to Hallek 2008 as modified by Cheson 2012. GS-9973 plasma levels were obtained concurrently with plasma chemo/cytokine levels and phospho flow analysis of circulating leukemic cells. Results: 27 subjects are still on treatment (Rx) for a median of 22 weeks. Median age was 73 (range 51 - 89), 66% were male. The median number of prior Rx regimens was 3 (range 1-8). Prior Rxs included anti-CD20 antibodies (95%), alkylating agents (86%; bendamustine 64%) and fludarabine (68%); 9 subjects had 17p deletions/TP53 mutations and 17 had other poor prognosis mutations/deletions. Results: 41 subjects were treated for at least 8 weeks and had ≥ 1 efficacy assessment. Per investigator, 40 (91%) subjects experienced reduced tumor bulk; 28 (64%) achieved a decrease of ≥ 50%. Results of the independent response assessments are pending and will be presented. GS-9973 was generally well tolerated. Rx emergent adverse events occurring in ≥ 10% of subjects are listed in the Table. Reversible Grade 3 or 4 ALT/AST elevations occurred in 2 (4.5%) subjects. 2 subjects died while on study: 1 from progressive disease, 1 from sepsis. The mean absolute lymphocyte count increased from 46,410 to 68,850/uL by day 8 and then declined; in 38 paired samples, mean leukemic cell pSyk MdFI levels decreased from 222 (D1) to 186 (D8). Conclusions: GS-9973 given on this dose and schedule was generally well tolerated and demonstrated substantial activity in subjects with CLL, including those with poor prognostic features. Clinical trial information: NCT01799889. Grade 1 2 3 4 All Diarrhea 18 2 1 21 (48%) Fatigue 9 9 2 20 (45%) Nausea 11 3 1 15 (34%) Headache 11 2 13 (30%) Dizziness 12 1 13 (30%) Anemia 1 6 3 1 11 (25%) Decreased appetite 7 3 10 (23%) Pyrexia 6 4 10 (23%) Constipation 8 1 9 (20%) Cough 5 3 8 (18%) Peripheral edema 5 1 6 (14%) Vomiting 5 1 6 (14%) Chills 6 6 (14%) Upper respiratory tract infection 1 5 6 (14%) Neutropenia 3 2 5 (11%)
Description of ALK+ NSCLC patient characteristics and ALK testing patterns.
Authors: Heather A. Wakelee, Medha Sasane, Jie Zhang, Alexander R. Macalalad, Philip J Galebach, John Jarvis, Andrew James Kageleiry, Qing Huang, Kenneth W. Culver, Eric Qiong Wu, Annie Guérin
Journal: Journal of Clinical Oncology (2014)

8062 Background: Anaplastic lymphoma kinase (ALK) gene rearrangements are seen in 4-8% of non-small cell lung cancer (NSCLC) patients (pts). Historically these pts have been reported to be predominantly young never-smokers with adenocarcinoma histology. ALK translocations have also been more frequently reported in Asian pts. This study investigated ALK+ NSCLC pts' characteristics and physicians' ALK testing practices in the US. Methods: A panel of US community oncologists was surveyed about their ALK testing practices for NSCLC pts and key considerations and challenges encountered in ALK testing. Also, ALK+ NSCLC pts' medical charts were reviewed by the responding physicians to collect pt-level information. Results: A total of 27 physicians participated and pt-level data was collected for 273 ALK+ NSCLC pts. In this sample, ALK+ NSCLC pts were older, racially diverse, had mixed smoking histories, and 81% had adenocarcinoma. Not all pts received ALK testing upon NSCLC diagnosis; 47 (16%) pts received one systemic therapy while 7 (14%) received 2 systemic therapies prior to ALK testing. After detection of ALK rearrangements, 181 (66%) pts received crizotinib as next-line therapy, 80 (29%) received chemotherapy, and 12 (4%) did not receive further anticancer treatment. Participating physicians reported an average ALK testing rate of 67% of pts in the past 12 months. When asked about issues encountered when testing for ALK, physicians reported inadequate tissue sample (63%), delay in reporting results (41%), and inconclusive results (37%) as the top three challenges. Conclusions: In this retrospective chart review in a sample of US oncology practices, ALK+ NSCLC pts were older and racially diverse with mixed smoking histories and cancer histologies. These results challenge preconceived notions of the phenotype of ALK+ NSCLC pts. N=273 Age, mean ± SD [median] 65.1 ± 12.2 [67] N (%) Age ≥65 at primary diagnosis 152 (56) Male 142 (52) Race White 162 (59) Black or African American 49 (18) Asian 36 (13) Hispanic or Latino 22 (8) Other 4 (1) Smoking status Never smoker 90 (33) Light smoker (<10 pack-year) 91 (33) Smoker (≥10 pack-year) 89 (33) Not available 3 (1) Histology Adenocarcinoma 222 (81) Mixed 30 (11) Large cell carcinoma 13 (5) Squamous cell carcinoma 8 (3)
Role of religiosity in medical decision making among patients with colorectal cancer.
Authors: Mosmi Surati, Rachel Davis, Sarah T. Hawley, Paul Abrahamse, Kevin C. Ward, Ikuko Kato, Arden M. Morris
Journal: Journal of Clinical Oncology (2013)

9579 Background: Physician-based medical decision making (DM) has declined in favor of more patient-centered approaches. Most studies indicate that patients want to be involved; however, the level of desired involvement varies between patients wanting to make their own decisions and those preferring to leave decisions to physicians. Little is known of the factors associated with DM preferences. Given data demonstrating the influence of religion among cancer patients, we explored religiosity and decision making preferences in colorectal cancer (CRC) patients. Methods: We surveyed a population-based cohort of Stage III CRC patients from the Detroit and Georgia SEER registries. Patients were queried about desired level of involvement in DM, trust in physicians, religiosity, receipt of adjuvant chemotherapy, and demographics. Religiosity was assessed using the Holland System of Belief Inventory. Physician trust was assessed using the Wake Forest Physician Trust scale. Responses were collected along a Likert scale and results were dichotomized. Surveys were analyzed using univariate and bivariate methods. Results: Thus far, 430 CRC patients have responded (56% response rate). The median participant age is 61 years, 45% are female, and 19% are black. 54% indicated a preference for shared DM, 35% prefer “doctors to make [their] decisions”, and 11% prefer to “make [their] own decisions”. The distribution did not differ by age, gender, race, income, or level of education. Higher religiosity was associated with higher trust in the surgeon (p=0.007) but not the oncologist (p=0.3). Patients with higher religiosity scores and higher physician trust were more likely to prefer that their doctors make the decisions (p= 0.023, p&lt;0.001). Preference for physician DM was associated with higher receipt of adjuvant chemotherapy (p=0.002). Conclusions: Patients who were more religious preferred to leave medical DM to physicians. Those who relied on physician DM were more likely to receive chemotherapy. This association may be mediated through higher trust. Understanding the influence of religiosity may be a tool to help providers get their patients appropriate cancer care.
Attitudes about chemotherapy for Japanese patients with or without cancer: Doctors, nurses, and the general public
Authors: K. Kubota, K. Nagai, Y. Nishiwaki, T. Sugiura, S. Tsuchiya, K. Matsui, A. Tada, Y. Nishimura, M. Kawahara
Journal: Journal of Clinical Oncology (2007)

17062 Background: A prospective survey in England demonstrated that patients with cancer were much more likely to accept radical treatment with minimal chance of benefit than people who did not have cancer (Slevin et al. Br Med J 1990; 300: 1458–60). We compared responses of Japanese patients with cancer with those of a control group of physicians, nurses, and patients without cancer in assessing personal cost-benefit of chemotherapy using the same questionnaire with Slevin's study. Methods: Subjects were asked with questionnaires whether of not to accept intensive and mild chemotherapy with a supposed minimum chance of effectiveness. 153 patients with cancer, 265 controls, 213 doctors, 397 nurses, and 51 patients without cancer were subjects of the study. Results: Percentage of subjects who accepted intensive chemotherapy with a supposed minimum chance of effectiveness (1% chance of cure, 3-month prolonging life, 1% relief of symptoms) by subject group were as follows: cancer patients; 62/55/52, doctors; 27/32/4, nurses; 11/12/5, non-cancer patients; 35/40/36, controls; 23/24/15, respectively. Conclusions: More patients with cancer than people without cancer accepted treatments giving the minimal benefit for cure, prolonging life or palliation of symptoms. Interestingly, the results in Japanese survey were similar to the previous study in England. No significant financial relationships to disclose.
The Health Related Quality of Life Is Maintained Following Treatment of Indolent Non-Hodgkin's Lymphoma Patients with the Novel Effective Antibody Radionuclide Conjugate 177lu-Satetraxetan-Lilotomab
Authors: Arne Kolstad, Matthew Beasley, Michael Bayne, Ingemar Lagerlöf, Noelle O'Rourke, Jostein Dahle, Laurie Baylor Curtis, Åse Østengen, Simon Turner, Roy Hartvig Larsen, Harald Holte
Journal: Blood (2016)
Comparative health care (HC) costs and quality of care in five cancer types by physician office (PO) and hospital outpatient (HOP) settings.
Authors: Maxine Fisher, Yeun Mi Yim, Art Small, Rakesh Luthra, Joseph Singer, Jay Schukman, Barbara L. McAneny, Rajeshjwari Punekar, Jennifer Malin
Journal: Journal of Clinical Oncology (2014)

6528 Background: This study compares HC costs, resource utilization (RU), and select quality of care measures in cancer pts receiving treatment (tx) in PO or HOP. Methods: This retrospective study used medical & pharmacy claims (1/2006 - 8/2012) from 14 US health plans to identify early breast cancer (eBC), metastatic BC (mBC), metastatic lung cancer (mLC), metastatic colorectal cancer (mCRC), and non-Hodgkin’s lymphoma (NHL) or chronic lymphocytic leukemia (CLL) pts initiating IV chemotherapy (ctx) or biologic tx. Death date was confirmed by Social Security Administration Death Master File (SSDI). RU, quality measures of ctx and hospitalization 30 days prior to death & GCSF use were compared using T-test or chi-square test. Multivariate analyses assessed differences in mean annual HC costs. Results: 18,740 pts were identified (69% PO vs. 41% HOP) with mean age 51.6 yrs, Deyo-Charlson score of 5.37, and follow-up of 2.2 yrs. PO had higher mean outpatient visits (21.8 PO vs. 21.2 HOP), other outpatient services (50.8 PO vs. 48.5 HOP), and pharmacy claims (35.1 PO vs. 33.6 HOP), but lower inpatient hospitalizations (0.7 PO vs. 0.8 HOP) and ER visits (0.3 PO vs. 0.4 HOP) [p<0.001]. Proportion of pts using GCSF was significantly lower in HOP (PO 73.3% vs 57.2% HOP, p<0.001). There were no differences in ctx or hospitalizations 30 days prior to death. Mean (median) annual HC cost in HOP was higher than PO ($122,473 [$123,075] vs. $82,773 [82,424] p<0.001). In multivariate analyses, mean annual cost was 8.3% higher in HOP (95% CI: 6.3-10.3%) Conclusions: Pts receiving care in PO were associated with lower HC costs than HOP. Chart review and pt satisfaction studies are ongoing to further characterize the care received in PO and HOP settings. Cancer type N (%) PO (N=12,899) HOP (N=5,841) Mean S.D Median Mean S.D Median eBC* 8896 (47.5%) $54,092 $45,789 $40,691 $81,352 $76,929 $58,070 mBC* 4145 (22.1%) $93,725 $72,560 $76,119 $119,211 $103,118 $90,061 mLC* 1890 (10.1%) $143,290 $94,335 $126,453 $196,288 $154,921 $166,281 mCRC* 1581 (8.4%) $166,950 $104,804 $152,644 $238,095 $162,490 $216,686 NHL/CLL* 2228 (11.9%) $76,148 $113,660 $50,864 $123,773 $144,962 $75,974 *Statistically significant at p-value=0.01.
Long-term follow-up results of a phase I/II study of concurrent chemoradiotherapy for localized nasal NK/T-cell lymphoma (NKTCL): JCOG0211.
Authors: Motoko Yamaguchi, Kensei Tobinai, Masahiko Oguchi, Naoki Ishizuka, Yukio Kobayashi, Yasushi Isobe, Kenichi Ishizawa, Nobuo Maseki, Kuniaki Itoh, Noriko Usui, Izumi Wasada, Satoshi Ishikura, Yoshikazu Kagami, Tomohiro Kinoshita, Tomomitsu Hotta, Kunihiro Tsukasaki, Kazuo Oshimi
Journal: Journal of Clinical Oncology (2012)

8050 Background: Concurrent chemoradiotherapy has been regarded as one of the standard management for localized nasal NKTCL. However, its long-term efficacy and toxicity is not known. Methods: The JCOG0211 trial is a phase I/II study of concurrent chemoradiotherapy consisting of radiotherapy (RT) of 50 Gy and 3 cycles of DeVIC (carboplatin, etoposide, ifosfamide, dexamethasone) for newly diagnosed, localized nasal NKTCL (JCO 2009). Patients (Pts) with newly diagnosed, localized diseases (IE &amp; contiguous IIE with cervical node involvement) who were 20-69 yrs of age with PS 0-2 were eligible. 3-D conformal RT planning with a wide margin (+ 2 cm to the gross tumor, the entire nasal cavity and the nasopharynx) and a 2-step cone down were required. 33 pts were enrolled in the study, 27 of whom were treated with RT and a 2/3-dose of DeVIC, which was selected as the recommended phase II dose in the preceding phase I portion of the trial. All pts completed RT without any protocol violations. Long-term follow-up results on overall survival (OS), progression-free survival (PFS) and toxicity were evaluated. Results: The median follow-up was 69 months (range, 62-96). The pt (N=33) characteristics were as follows: median age 54 yrs (range, 21-68); stage IIE 33%; B symptom (+) 36%; elevated serum LDH 21%. %5-yr OS and PFS were 73% (95%CI, 54-85%) and 67% (95%CI, 48-80%), respectively. 11 pts (33%) experienced disease recurrence. Two achieved a 2nd CR by salvage chemotherapies followed by allogeneic stem cell transplantation, and the remaining 9 pts died of disease. There was no observed death and disease progression after 34 and 31 months, respectively. One pt experienced Grade 3 irregular menstruation for 3 years. No other Grade 3 or 4 late non-RT-associated adverse events (AEs) were observed. One pt received plastic surgery due to Grade 4 RT dermatitis. No other Grade 3 or greater RT-associated late AEs were encountered. Conclusions: Both survival benefit and disease control from concurrent chemoradiotherapy with RT and DeVIC are maintained during a 5-yr follow-up, indicating the excellent efficacy of this approach as a first-line therapy for localized nasal NKTCL. Long-term toxicity is acceptable.
Assessing clinical appropriateness on a population basis within a regional cancer network.
Authors: Paolo Giovanni Casali, Lisa F. Licitra, Rosaria Bufalino, Fabrizio Pizzo, Marco Tricomi, Rossella Bertulli, Michele Torresani, Giordano D. Beretta, Roberto Labianca, Salvatore Siena, Maurizio Bersani, Marco Pierotti
Journal: Journal of Clinical Oncology (2012)

TPS9155 Background: The Lombardia Cancer Network (ROL: “Rete Oncologica Lombarda”) connects all cancer resources of the Lombardia region, with 9,000,000-plus citizens, to improve quality of cancer care and patient data sharing. Assessment of appropriateness of cancer care on a population basis is an aim. Implementation of electronic records is partial and heterogeneous. However, clinical discharge reports for both inpatients and oupatients are released as “pdf” files onto a secure regional health care information system, accessible by physicians. Methods: ROL includes 58 oncology premises. Clinical practice guidelines are annually updated within this oncology community. For each solid cancer, guidelines enlist all main clinical presentations (“disease phases”), along with their “treatment options” (either “standard”, “individualized”, or “investigational”). ROL upgraded the existing non-structured electronic clinical discharge report into a field-based resource, with both free-text (17) and codified (25) fields. Two codified fields enlist, respectively, disease phases as per guidelines, and the corresponding treatment options. If they match, the strategic medical decision is considered tentatively “appropriate”. Even the report of a single encounter within a disease phase is enough to make this work. Results: Currently, the instrument is being incorporated stepwisely within the information systems of all oncology facilities, though a central web-based tool is also available. More than 36,000 reports were released in 2011. Appropriateness assessment proved feasible on a pilot set of patients. A research project is underway to detect causes of mistakes and mismatches, by automatically analyzing free-text fields. A training effort is ongoing to improve clinicians’ learning curve on semantics. Conclusions: To assess clinical appropriateness on a population basis in a large region, we exploited two key bottlenecks: 1) the electronic discharge report, within patient information flows, to cope with a variety of local information systems; 2) the disease phase, within the cancer-specific clinical decision-making process, to cope with a likely lack of reports from a substantial proportion of encounters.