tbuckley/cabot-search huggingface dataset:
Cetuximab in combination with docetaxel (T) in patients with operable, triple-negative breast cancer (TNBC): Preliminary results of a multicentre neoadjuvant pilot phase II study.
Authors: Jean Marc Nabholtz, Marie-Ange Mouret-Reynier, Isabelle Van-Praagh, Véronique Servent, Jean-Philippe Jacquin, Anne-Véronique Bourcier, Francesco Del Piano, Pascale Dubray-Longeras, Beatrice Nayl, Catherine Abrial, Fabrice Kwiatkowski, Marie-Mélanie Dauplat, Nina Radosevic-Robin, Anne Cayre, Nancy Uhrhammer, Yannick Bidet, Nassera Chalabi, Yves-Jean Bignon, Frederique Penault-Llorca, Philippe Chollet
Journal: Journal of Clinical Oncology (2013)

1057 Background: Cetuximab is an antiboby targeting the epidermal growth factor receptor (EGFR) to which a role has been suggested in TNBC. Therefore, we evaluated the combination of docetaxel with cetuximab as neoadjuvant therapy of operable TNBC. Methods: 35 patients with stage II-IIIA disease were prospectively included in this multicentre pilot study. Systemic therapy (ST) consisted of 6 cycles of T (100 mg/m2) q.3 weeks, in combination with weekly cetuximab (first dose : 400mg/m², then : 250 mg/m²/week) for 6 cycles. All patients underwent surgery at completion of ST. Complete pathologic response (pCR) was the primary endpoint (Sataloff : J Am Coll Surg 1995 ; Chevallier : Am J Clin Oncol 1993), with toxicity and biologic ancillary studies as secondary endpoints. Results: Patients characterisctics are as follows : mean age 48 [28-67] ; T1 : 3%, T2 : 73%, T3 : 24% (mean tumor size : 40 mm [15-100]) ; N0 : 61% and N1-N2 : 39%; invasive ductal carcinoma : 100%; Scarff-Bloom-Richardson Grade III : 73%, grade II : 27%. The median number of cycles was : T : 6 [1-6], cetuximab : 15 [1-18]. Pathological complete response was 24% according to Chevallier and Sataloff’s classifications and 28% if we consider response in breast. Preliminary results on 23 patients show an overall clinical response rate of 57% (22% CR). Conservative surgery was performed in 75% of cases. Skin toxicity was the main side-effect : grade II : 39%, grade III : 36%, grade IV : 3%. Neutropenia grade IV : 12.7%, febrile neutropenia : 1.3%, infection : 0%. Hand-foot syndrome grade III : 3%, grade II : 3%. Ungueal toxicity grade III : 3%, grade II : 33%. Conclusions: These preliminary results suggest that cetuximab in combination with Tappears to have a modest efficacy in operable TNBC. Clinical trial information: NCT00600249.
A longitudinal assessment of treatment-related differences in quality of life among prostate cancer patients
Authors: A. Giedzinska-Simons, K. M. Christie, B. E. Meyerowitz, M. Gross, D. B. Agus
Journal: Journal of Clinical Oncology (2007)

15605 Background: Physicians increasingly are asked about changes in quality of life (QOL) following treatment. This is especially relevant for prostate cancer (PC), a disease for which different primary treatments expose patients to differing risks of adverse effect with similar expected benefits in terms of survival. Few studies have compared QOL for the major treatment approaches in a prospective, longitudinal design. Methods: 53 PC patients completed mailed questionnaires assessing general, emotional, social, functional, physical, and prostate-specific QOL with the FACT; stress with the Impact of Events Scale-R (IES-R); and mood with the Positive and Negative Affect Schedule. Data were collected prior to treatment and at 1 month and 6 months post-primary disease treatment. Patients’ primary treatments were radical prostatectomy (RP; N=22), radiation (N=16), or conservative therapy (androgen deprivation treatment only (ADT); N=15). Responses were compared in a mixed-factorial ANCOVA design, controlling for disease severity (Gleason score) and age. Results: Although there were no main effect differences by treatment group, treatment by time interactions emerged for physical QOL (p=.002), stress (p=.04), and negative affect (p=.01). Examination of patterns of response indicated that physical difficulties remained fairly consistent for RP and radiation patients over time, whereas ADT patients showed a gradual decline in physical QOL. For stress and negative affect, RP patients reported highest levels of distress prior to treatment and experienced a gradual recovery over time. Radiation patients followed a similar, although less dramatic, trajectory for stress but showed little change in negative affect. ADT patients had relatively low levels of stress at each time point. Their levels of negative affect were similar to those of radiation patients. Conclusions: Even after controlling for age and disease severity, this examination of patient QOL over time suggests the pre-treatment period is especially stressful for RP patients, and that ADT patients exhibit a gradual decline in physical QOL over time. These results may help physicians anticipate and discuss treatment-specific trends in QOL with their patients, thus enhancing patient care. No significant financial relationships to disclose.
Relationships among financial distress, emotional symptoms, and overall distress in insured cancer patients.
Authors: Yu-Ning Wong, Michael J. Hall, Karen Mechanic, Daniel M. Geynisman, Caitlin Meeker, Marijo Bilusic, Elizabeth R. Plimack, Margaret von Mehren, Lainie P. Martin, Kristen M. Kreamer, Brian Egleston
Journal: Journal of Clinical Oncology (2014)

6540 Background: Cancer care can be a financial burden, even among those with insurance. Overall Distress (OvDis) in cancer patients (pts) may be caused by many factors including Emotional Symptoms (EmSx). We examined the degree to which Financial Distress (FinDis) affected both OvDis and EmSx. Methods: We surveyed pts from medical oncology clinics about demographics, clinical information and the InCharge Financial Distress/Financial Well-Being Scale (range 1-10, lower scores indicating greater FinDis). Overall distress (OvDis) was measured using the NCCN distress thermometer (DT) (range 0-10, higher scores worse). As part of the DT, pts also responded to a list of symptoms including EmSx(i.e. depression, anxiety). We used linear regression and ANOVA to investigate potential pathways linking FinDis, EmSx and OvDis. Accrual is ongoing. Results: Of 60 pts recruited, median age was 64 years (34-85), 53% were male, 32% were working, 28% had self reported annual income >$100,000, 100% were insured, 69% had prior chemotherapy. 60% had clinically relevant DT scores ≥ 4 (median 5, 0-10), 58% reported at least one EmSx. The most common EmSx were worry(44%) and nervousness (34%). Median FinDis score was 6.5 (1-10). Evaluating the impact of each separately, FinDis and EmSx explain 30% and 39.6% of the variability in among OvDis scores respectively. After accounting for EmSx, FinDis explained 10.1% of the variability in OvDis (full model R2=0.497). Conversely, after accounting for FinDis, EmSx accounted for 19.75% of the variability in OvDis. Using linear regression, a 1 unit increase in FinDis was associated with a 0.79 unit worsening in DT (p<0.001). After adding EmSx, a 1 unit increase FinDis was associated with a 0.51 worsening in DT (p=0.002). The attenuation of the FinDis effect due to EmSx was significant (p=0.003). Conclusions: Even among this group of affluent pts seen at a tertiary referral center, OvDis, FinDis, and EmSx were common and inter-related. Even among pts who are insured, FinDis may play a profound role on both EmSx and OvDis. Focused interventions that help pts navigate insurance obstacles and address other financial concerns may help to reduce FinDis and EmSx and thus in turn reduce OvDis among cancer pts.
Using practice algorithms to deliver cancer survivorship care.
Authors: Guadalupe R. Palos, Fran Zandstra, Ludivine Russell, Jacklyn J Flores, Yvette DeJesus, Lewis E Foxhall, Maria Alma Rodriguez
Journal: Journal of Clinical Oncology (2012)

e19625 Background: Clinical practice algorithms provide a framework to guide providers’ practice in delivering care to long-term cancer survivors. Here we describe how algorithms were developed in a comprehensive cancer center and types of metrics used to evaluate their feasibility. Methods: Survivorship practice algorithms were based on a multidisciplinary care approach successfully used to build screening and treatment algorithms. This model consisted of four phases: development, adoption, implementation, and evaluation of algorithms. Phase 1, expert clinicians and researchers identified and agreed upon a specific cancer site. Group-consensus and literature reviews/syntheses were used to determine eligibility criteria to transition patients to survivorship care. Phase 2, reviews and approval processes were conducted by credentialing and regulatory committees to ensure adoption of the algorithms into clinical practice. Phase 3, pilot programs were conducted to implement the algorithm(s) in disease-specific survivorship clinics. Phase 4, metrics to evaluate progress included the number of algorithms and providers’ use of and adherence to the algorithms. Results: Between 09/2008 – 12/2011, nine multidisciplinary disease-specific survivorship clinics were operationalized. Thirty-seven practice algorithms were developed to provide survivorship care based on each survivor’s specific needs. The algorithms’ framework included: 1) surveillance for recurrent or new primary malignancies; 2) primary and secondary cancer prevention recommendations; 3) management of toxicities and latent treatment effects; and 4) assessment of psychosocial functioning. Conclusions: Practice algorithms provide an organized plan to deliver comprehensive and holistic care to long-term survivors. Given the projected increase in cancer survivors, further research is needed to determine how practice algorithms impact providers’ practice and survivors’ outcomes.
Survival trends of myeloma patients in the new millennium.
Authors: Charise Gleason, Ajay K. Nooka, Amelia A. Langston, Nishi N Shah, Jonathan L. Kaufman, Sagar Lonial
Journal: Journal of Clinical Oncology (2014)

e17694 Background: For patients with multiple myeloma (MM), survival outcomes have significantly improved in the last decade owing to the expeditious usage of proteasome inhibitors and immunomodulatory drugs in treatment of MM. Nevertheless, the survival benefits seen are not uniform across all sectors. We performed a population based analysis using the Surveillance, Epidemiology, and End Results (SEER) database to assess the overall survival (OS) differences in various patient groups. Methods: Patients who had a diagnosis of MM (International Classification of Diseases for Oncology, 3rd Edition code 9732/3) were identified in the SEER 18 database diagnosed between January 2002 and December 2007. Patients were divided into cohorts based on age categorization at diagnosis: ages 15 to 44, 45 to 54, 55 to 64, 65 to 74 and 75 to 84 years, as well as sex and race. OS was estimated using the Kaplan-Meier method, and Cox regression was used to estimate predictors of patient survival. Results: In total, 25,897 patients with MM diagnosis were identified. Median (range) age is 70 (18-104) years. The median overall survival (OS) was 30 months (95% confidence interval (CI): 29.22 months - 30.78 months). Graded improvement in median OS was seen for all patients between the years 2002 (26 months) to 2007 (34 months). Compared with patients who were diagnosed in 2002, the hazard ratio (HR) for patients diagnosed in 2007 was 0.86; P<0.000). Compared with patients who were aged 15-44, the hazard ratio (HR) for patients 45 to 54, 55 to 64, 65 to 74 and 75 to 84 years were 1.17; P=0.005, 1.46; P=0.000, 2.08; P=0.000, 3.24; P=0.000 and 5.54; P=0.000, respectively. Females had HR of 0.92 (95% CI 0.89-0.95; P<0.000) compared to males. Blacks had HR of 1.08 (95% CI 1.04-1.12; p<0.000) compared to Whites. Conclusions: OS improved among all patients, but the magnitude of improvement is higher among the younger patients. Female gender and White race were better predictors of survival.
Inadequate family history assessment by oncologists as a physician barrier to referral for cancer genetics evaluation.
Authors: Samuel Guan Wei Ow, Yvonne Fong Ling Yong, Wei Shieng Chieng, Pyar Soe Phyu, Soo-Chin Lee
Journal: Journal of Clinical Oncology (2013)

1535 Background: Cancer genetics programs have been established in tertiary cancer centers in Asia for more than a decade. However, the proportion of high-risk patients who are referred for genetic evaluation remains low, and may be attributed to physician and patient barriers. Methods: We reviewed 3-generation genograms of 6301 cancer (CA) patients constructed by a trained cancer genetics counselor at our centre between 2001 and 2012, and identified 1092 (17.3%) patients with suspected hereditary cancer syndromes. 618 patients were estimated to have ≥10% chance of carrying a BRCA1/2 mutation. Their case records were reviewed to determine the referral pattern to the cancer genetics clinic. Results: Of the 618 high risk patients, 420 (68%) had young onset CA (age &lt;40), 112 (18.1%) were breast CA families, and 58 (9.4%) were breast and ovarian CA families; only 164 (26.5%) were seen in the cancer genetics clinic. Of the 391 records reviewed so far, 132 cases (33.8%) were referred for genetic evaluation. A good family history (FH), defined by obtaining CA history in 3 consecutive generations, was obtained by the primary oncologist in 52.2%, compared to adequate smoking and drinking history in 64.7% of cases (p&lt;0.001). Taking a good FH increased the likelihood of oncologists suspecting hereditary breast and ovarian CA syndrome (50% vs 32.1%; p&lt;0.001), with 79% (128/162) of physician-suspected cases referred for genetic counseling. Young onset CA was more likely to arouse physician suspicion (46.9%) compared to other indications (30.5%, p=0.002). Of the 259 high-risk cases that were not referred, lack of FH evaluation by the oncologist was the most common reason (41.3 %), followed by lack of suspicion despite taking a FH (34.7 %), patient refusal (8.6%), and planned but no formal action (1.6%). Conclusions: Failure to take a good FH and failure to recognize high-risk CA patients despite taking a FH are important physician barriers that resulted in only a third of high-risk breast or ovarian CA patients being referred for cancer genetics evaluation at a tertiary cancer center in Asia. Systematic FH screening by genetic counselors, clinic-based protocols, and continued physician education may rectify this barrier.
Preclinical and clinical data for tbo-filgrastim: A short-acting filgrastim.
Authors: Anton Buchner, Udo W. Mueller, Peter Bias, Andreas Engert
Journal: Journal of Clinical Oncology (2013)

e13555 Background: Tbo-filgrastim is a G-CSF approved in the US as a biologic under the BLA 351(a) pathway, for reducing duration of severe neutropenia (DSN) in patients with non-myeloid malignancies receiving chemotherapy (CTx) associated with a clinically significant incidence of febrile neutropenia (FN). Here, we summarize data from the development program (16 preclinical studies; 2 Phase I and 3 Phase III clinical studies). Methods: Preclinical: The PK, safety pharmacology, PD, and toxicology of tbo-filgrastim vs reference filgrastim were investigated in 3 in vitro studies and 13 animal model studies. Clinical: The PK/PD of tbo-filgrastim and filgrastim were compared in 2 Phase I studies in 200 healthy volunteers. The safety and efficacy of tbo-filgrastim were compared with filgrastim in 3 Phase III studies in 677 patients receiving CTx for breast cancer (BC), lung cancer (LC) and non-Hodgkin lymphoma (NHL). The BC study, in which DSN was the primary parameter, was placebo controlled. Results: Preclinical: Binding affinity to the human G-CSF receptor and growth-promoting activity were comparable between tbo-filgrastim and filgrastim in vitro. In vivo, no relevant differences were seen between tbo-filgrastim and reference filgrastim in PK, PD, safety, or tolerability in animal models. Clinical and laboratory findings, gross pathology and histopathology in animal models were similar to filgrastim. Clinical: tbo-Filgrastim was safe, effective, and comparable to filgrastim in the prevention of FN. DSN, absolute neutrophil count (ANC) nadir, and time to ANC recovery were comparable. The incidence of FN was low (mean of 12.1%, 15.0%, and 11.1% in Cycle 1 of the BC, LC, and NHL studies, respectively), with no significant differences between agents. In the BC study, in Cycle 1, DSN was 1.1 vs 3.9 days for tbo-filgrastim and placebo, respectively. The efficacy of tbo-filgrastim was independent of the myelotoxic potential of CTx. Immunogenicity and incidence of binding and neutralizing antibodies were low and comparable. Conclusions: The safety profiles of tbo-filgrastim and filgrastim were similar and characteristic of filgrastims. Tbo-filgrastim was superior to placebo and equivalent to filgrastim in reducing DSN after myelotoxic CTx. Clinical trial information: 2004-001452-36, 2004-001450-84, 2004-001449-13.
Is there a relationship between testosterone levels at the end of short-term androgen deprivation therapy and outcomes in intermediate risk prostate cancer? Prospective data from a phase III trial.
Authors: Abdenour Nabid, Marie-Pierre Garant, Eric Vigneault, Luis Souhami, Celine Lemaire, Marc-Andre Brassard, Boris Bahoric, Robert Archambault, Francois Vincent, Thu-Van Nguyen-Huynh, Redouane Bettahar, Derek R Wilke
Journal: Journal of Clinical Oncology (2017)

78 Background: The purpose of this analysis was to assess whether the testosterone level measured at the end of short term androgen deprivation therapy (STADT) and prostate radiotherapy (RT) has an impact on treatment outcomes in patients with intermediate risk prostate cancer (IRPC) treated on a randomized trial (PCS III ClinicalTrials.gov #NCT00223145). Methods: From December 2000 to September 2010, 400 patients with IRPC received 6 months of STADT (bicalutamide 50mg die and goserelin 10.8mg x 2) and RT. Castrate level of testosterone was defined as &lt;1.7 nmol/L: lower level &lt;0.7 and upper level 0.7-1.7. In 347/400 patients, testosterone levels were available at the end of STADT and were divided into 3 groups based on measured testosterone levels: &lt;0.7, 0.7 to 1.7 and &gt;1.7 nmol/L. Patient’s characteristics were compared with ANOVA and Fisher’s exact test. Biochemical failure, prostate cancer recurrence and death were compared with Cox regression. Results: Patient’s characteristics were well balanced between the 3 groups with no statistical difference for age, performance status, PSA at start, Gleason score and stage. At the end of STADT 55.3% (192/347) presented testosterone levels &lt;0.7 and 38.9% (135/347) levels between 0.7 and 1.7 for a total of 94.2% (327/ 347) reaching castrate levels ≤1.7 nmol/L. In 5.8% of patients (20/347) a castrate testosterone level was not achieved. With a median follow-up of 8.1 years, outcomes are shown in the table. Conclusions: In IRPC patients treated with STADT and RT, the majority of patients (94.2%) achieve a castrate level of testosterone (&lt;1.7 nmol/L). Although we could not show a difference in outcomes between castrate and non-castrate patients, these data have to be viewed with caution given the small number of non-castrate patients studied. Source of Funding: AstraZeneca Pharmaceuticals Grant. Clinical trial information: NCT00223145. [Table: see text]
Do oncology patients in an outpatient hospital receive the same care as patients in an office/clinic setting? A case study evaluating patients with non-metastatic HER2+ breast cancer (BC) receiving adjuvant trastuzumab.
Authors: Deepa Lalla, Melissa Brammer, Annie Guérin, Geneviève Gauthier, Philippe Giguere-Duval, Eric Q. Wu, Eduardo Santos
Journal: Journal of Clinical Oncology (2013)

e11603 Background: It is unknown if quality of care received by patients (pts) with BC is impacted by the location at which care is received. Using a sample of pts with HER2+ BC receiving adjuvant trastuzumab (T), we compared T treatment patterns between pts treated in office/clinic (MD) or outpatient hospital (HOSP) settings. Methods: Non-metastaticBCadult women who received ≥2 T infusions in an MD or HOSP setting from 2008-2012 were selected from the US-based Humana database. Based on the site of care where T was received, pts were classified into MD or HOSP cohorts. Pts were followed from first T infusion date to treatment discontinuation, first metastasis, or end of continuous eligibility, for a maximum of 12 months (mos). T treatment duration, discontinuation (treatment gap of ≥45 consecutive days), and the proportion of pts completing the recommended 12 mos treatment indication were compared between cohorts. Results: 730 pts were included; 67% received T in an MD setting vs. 33% in a HOSP setting. Differences between cohorts were observed in terms of healthcare insurance plan: more pts in the HOSP setting had Medicare coverage (55.5% vs. 67.1%; p=.003). Average T duration was shorter in the HOSP setting (MD cohort: 241.9 days ; HOSP cohort: 191.3 days). Among pts observed for 12 mos, a higher proportion in the MD cohort completed the 12-mo treatment (84.3% in MD vs. 75.6% in HOSP [p=.034]). After adjusting for confounding factors, the HOSP cohort was 2.4 times more likely to discontinue treatment compared to the MD cohort ( p&lt;.001). Conclusions: Duration of adjuvant T treatment for pts with non-metastatic HER2+ BC differed based on the site at which treatment was received. This suggests that oncology pts treated in an HOSP setting, vs. MD, may be at higher risk for treatment discontinuation or to receive a shorter course of treatment than recommended. Further research should explore the impact of these differing treatment patterns on outcomes.
Surveillance of long-term colorectal cancer survivors.
Authors: Guadalupe R. Palos, Katherine Ramsey Gilmore, Patricia Chapman, Weiqi Bi, Delrose Jones, Maria Alma Rodriguez
Journal: Journal of Clinical Oncology (2015)

e20596 Background: Advances in the treatment of colorectal carcinoma (CRC) have contributed to an increase in long-term survivors. Despite the advances made in this cancer, there is relatively little information regarding adherence with follow-up visits or recommended surveillance, i.e. colonoscopies, or CEA testing, in CRC survivors. This is particularly true of high-risk CC survivors receiving post-treatment care in academic cancer centers. Here, we report the results from a pilot evaluation of survivors followed over three years in a CRC survivorship clinic. Methods: Data for this evaluation came from the Cancer Survivorship Program, which has been collecting data on CRC survivors since 2010. The Quality Improvement Advisory Board approved this pilot. A total of 117 CRC survivors were identified as being alive at the time of data abstraction and having 2-3 arrived appointments between 9/01/2011 and 8/31/2014. The pilot sample included the first sequential 35 cases which met this criteria. Metrics collected included demographic, clinical, and survivorship care characteristics. Outcome variables were 1) receiving survivorship care, yes/no; 2) return to survivorship clinic within the designated window of time, yes/no, and 3) adherence with surveillance testing such as receiving a colonoscopy and CEA testing, yes/no. Data was summarized using simple descriptive statistics. Results: Of the 35 cases, 51% were diagnosed with Stage I–IV colon cancer (CC); X= 69 (SD = 9.9) and 49% with Stage I-IIIC rectal cancer (RC), X age = 66 (SD = 11.6). The majority in both cancer groups were female, Caucasian, X age = 68 (SD = 10.7), and 57% between 5-9 years post-treatment at their first visit. Clinicians’ adherence rates for colonoscopy recommendation were 100% across all 3 visits for both CC and RC survivors. CEA concordance rates were higher for CC survivors across all 3 visits. A stable trend was observed for survivors returning for care within the designated time frame. Conclusions: Long-term cancer survivors returned for care as recommended by providers in the CRC Survivorship Clinic. High adherence rates with recommended testing suggest clinicians are following the surveillance guidelines outlined in clinical algorithms.