tbuckley/cabot-search huggingface dataset:
A randomized trial of home-based exercise for patients receiving aggressive treatment and epoetin alfa for multiple myeloma: Hemoglobin (Hb), transfusion, fatigue and performance as outcomes
Authors: E. A. Coleman, E. Anaissie, S. K. Coon, C. B. Stewart, J. Shaw, B. Barlogie
Journal: Journal of Clinical Oncology (2004)

8026 Background: Over 60% of patients with multiple myeloma (MM) are anemic (Hb < 12 g/dL) at diagnosis. Nearly all become anemic during aggressive treatment for MM and many require red blood cell (RBC) transfusions. Anemia can contribute to fatigue, the most common and often the most distressing symptom for patients with cancer. Methods: A randomized trial with repeated measures compared the effects on fatigue and performance of a home-based exercise program that combines aerobic and strength resistance training with a usual care/control condition. Measurements were the Profile of Mood States (POMS) fatigue scale, Functional Assessment of Cancer Therapy - Fatigue (FACT-F) and 6-minute walk test. Patients were newly diagnosed with MM and were enrolled in an aggressive treatment protocol that included tandem peripheral blood stem cell transplants. All patients in the study received epoetin alfa according to an algorithm that allowed increases in Hb up to 15 g/dL before dose reductions or delays. Planned enrollment is 160. Results: The table below shows data from 82 patients with measurements at baseline just before induction chemotherapy and just before stem cell mobilization. Trends toward less fatigue and better performance are seen in the exercise group compared to the control group. Conclusions: These preliminary findings suggest exercise therapy during aggressive treatment for MM benefits patients by decreasing their fatigue and improving their performance status. No significant financial relationships to disclose.
Phase I trial of erlotinib with radiation therapy (RT) in patients with glioblastoma multiforme (GBM)
Authors: S. Krishnan, P. Brown, K. Ballman, J. Fiveash, J. Uhm, C. Giannini, F. Geoffroy, L. Nabors, J. Buckner
Journal: Journal of Clinical Oncology (2005)

1513 Background: EGFR inhibitors may potentiate the therapeutic efficacy of RT in GBM patients. To evaluate the toxicity and maximum tolerated dose (MTD) of erlotinib plus RT in patients with GBM, we performed the following phase I trial. Methods: Patients were stratified based upon the use of enzyme-inducing anticonvulsants (EIACs). Patients with resected or biopsied GBM were treated with erlotinib for a week prior to concurrent erlotinib and 6 weeks (60 Gy) of RT and maintained on erlotinib until progression. The erlotinib dose was escalated in cohorts of 3 with a starting dose of 100mg/day. Intrapatient dose escalation was not allowed. Response was evaluated by MRI and clinical assessment of neurological status every two months. Results: 20 patients were enrolled; 19 are evaluable. There were 14 males/5 females, median age 54 years; 7 had undergone biopsy only/ 5 subtotal resections/ 7 gross total resections. Current dose level is 150mg/day erlotinib for patients not on EIACs (group 1) and 200mg/day for patients on EIACs (group 2). MTD has not been reached. DLTs associated with treatment have occurred in Group 1 at 100mg (1 pt with stomatitis, n=7) and at 150mg (no DLTs, n=4). No DLTs have occurred in Group 2 at 100mg (n=3), 150mg (n=3) and 200mg (n=3) but dose was reduced to 150mg in 2 of 3 patients due to a bothersome rash. With a median follow-up of 189 days, there were 8 deaths and 13 progressions. Median time to progression was 161 days (95%CI: 109 to 216) and median survival was 386 days (95% CI: 278 to NR). Best objective response was known and evaluable in 13 patients: 9 had stable disease, 1 had no evidence of disease and 3 had early progression. Conclusions: Toxicity is acceptable at the current doses of erlotinib plus RT. Accrual continues on both arms with the addition of concurrent and adjuvant temozolomide in conjunction with erlotinib and RT. No significant financial relationships to disclose.
Phase II trial of second-line erlotinib and digoxin in patients with non-small cell lung cancer (NSCLC)
Authors: F. Kayali, M. A. Janjua, D. A. Laber, D. M. Miller, J. M. Day, G. H. Kloecker
Journal: Journal of Clinical Oncology (2009)

e19077 Background: There is laboratory evidence that digoxin sensitizes cancer cells to the induction of apoptosis by chemotherapy. Inhibition of the Na/K-ATPase enzyme by ouabain disturbs the intracellular ion composition of cancer cells, altering cellular homeostasis. This suggests that inhibition of the Na/K pump results in cellular sensitization of malignant, but not benign cells to induction of apoptosis. Epidemiologic studies also have shown beneficial effects of digitalis in breast cancer incidence. At ASCO 2007 our group presented a phase II study showing encouraging results by adding digoxin to bio-chemotherapy for melanoma. Erlotinib is one of the standard second-line treatments for NSCLC with a response rate (RR) of 10%. This study hypothesized, that adding digoxin to erlotinib may improve the RR and time to progression (TTP) in NSCLC. Methods: This was a phase II trial using daily 150 mg erlotinib and digoxin 0.25 mg. The digoxin dose was adjusted to keep levels between 1–2 ng/ml. Patients with progressive disease (PD) after chemotherapy were enrolled, if they had an ECOG 0–2 and good organ function. CT scans were done every 6 weeks. Treatment continued until PD or significant toxicity occurred. Results: Patient accrual lasted from 3/06–8/08 and was stopped early at time of interim analysis. Twenty eight patients were enrolled and 24, who completed at least 6 weeks of therapy, are presented here. All patients had unresectable stage III/IV at diagnosis. Median age was 61 (34–78), 14 were female, 17 had prior radiation (not involving the target lesions), 23 had one prior chemotherapy and 1 subject had two. Only one patient was a never smoker. Histologies were 50% adenocarcinoma, 30% squamous and 20% unspecified. One patient had a PR, 9 SD, and 14 PD. The median TTP was 61 days (9–366) and median survival 157 days (9–844). Side effects were similar to erlotinib single agent with no treatment related mortality. There were no unexpected or increased adverse events related to digoxin. Conclusions: Digoxin did not increase the response rate of erlotinib in the treatment of progressive NSCLC. TTP and survival seen in this study were similar to the published results with erlotinib alone. This combination does not warrant further clinical studies in NSCLC. No significant financial relationships to disclose.
Assessment of circulating tumor cells in breast cancer patients undergoing neoadjuvant chemotherapy
Authors: J. B. Smerage, D. F. Hayes, G. V. Doyle, L. W. Terstappen, M. E. Brown, A. F. Schott
Journal: Journal of Clinical Oncology (2006)

10079 Background: Circulating tumor cells (CTCs) are a valuable prognostic factor in metastatic breast cancer, suggesting that CTCs, if present, may be clinically useful in other breast cancer (BC) settings. This study prospectively evaluated CTCs before and after neoadjuvant chemotherapy (NACT) in patients with operable breast cancer. Methods: 7.5 or 30ml of blood were drawn in CellSave tubes from 26 Pts about to receive NACT (docetaxel + capecitabine followed by adriamycin + cytoxan) followed by surgery. CTC analysis is being performed at multiple time points. Data presented are from baseline (prior to first dose), post-NACT, and 3 months after surgery. CTCs were measured by immunomagnetic separation and automated fluorescent microscopy using the CellSearch System (Veridex/Immunicon Corp). Results: Baseline CTCs: For the first 11 pts CTCs were analyzed from 7.5ml of blood. 36% (4/11) had ≥1 CTC, 27% (3/11) had ≥2 CTCs. Of pts with detectable CTCs, the mean was 2.75 CTCs/7.5ml (range 1–4). To improve baseline sensitivity, 30ml blood was drawn from the subsequent 15 pts. One sample was not evaluable. 50% (7/14) had ≥1 detectable CTC and 29% (4/14) had ≥2 CTCs. Of pts with detectable CTCs, the mean was 3.0 CTCs/30ml (range 1–10). CTCs post-neoadjuvant therapy: All 26 pts had 30ml of blood drawn for CTC analysis. 27% (7/26) had ≥1 CTC, and 8% (2/26) had ≥2 CTCs. Using as threshold of ≥2 CTCs to define elevated, CTCs post-chemotherapy were compared to the pathologic complete response (pCR). Sensitivity was 10% (2 of 18 pts with residual disease had elevated CTCs). Specificity was 100% (0 of 7 pts with a pCR had elevated CTCs). This correlated to a positive predictive value of 100% and a negative predictive value (NPV) of 28%. CTCs 3 months after surgery: Of 21 pts analyzed, only one pt (5%) had a single CTC. Long-term follow-up blood collection is ongoing. Conclusions: CTCs are detectable in ∼30% locally advanced BC. All patients with CTCs after NACT had residual disease at surgery, and no CTCs were detected in patients with pCR. However, the absence of CTCs after NACT did not predict pCR. Pts will be followed to determine if CTCs correlate with recurrence and survival. [Table: see text]
Predictive factors of transcatheter arterial chemoembolization for hepatocellular carcinoma
Authors: H. Ishii, J. Furuse, K. Nakachi, E. Suzuki, S. Shimizu, M. Yoshino, M. Satake, T. Hayashi
Journal: Journal of Clinical Oncology (2007)

4541 Background/Aim: Although transcatheter arterial chemoembolization (TACE) has been widely used for the treatment of unresectable hepatocellular carcinoma (HCC), the optimal indication of the TACE has not been fully elucidated. Methods: The treatment outcomes after TACE were analyzed retrospectively to determine predictive factors of anti-cancer effect on HCC. The patient (pts) selection criteria were: 1) admission between 1992 and 2005, 2) diagnosis of fresh HCC, 3) no extrahepatic metastasis and 4) primary treatment with TACE. TACE was performed by selectively introducing a catheter into the hepatic artery and injecting gelatin sponge particles following an emulsion consisting of 2–5 ml of iodized oil (Lipiodol) and 20–50 mg doxorubicin hydrochloride. Lipiodol accumulation in tumors was regarded as an indication of necrosis. We defined complete response (CR) as disappearance or 100% necrosis of all tumors, and partial response (PR) as more than 50% reduction and/or more than 50% necrosis. Results: There were 270 pts who fulfilled the above criteria. According to Japan Integrated Staging, the number of T1, T2, T3 and T4 was 10, 59, 171 and 30, respectively. There were 52 CRs, 113 PRs, 77 who remained SD and 28 who showed PD/NE. The median survival months of CR, PR, SD and PD/NE were 50, 30, 15 and 5, respectively, and there was a significant differences between them. The logistic regression analysis revealed tumor multiplicity and vascular invasion (VI) were significantly associated with the objective response (CR or PR). The response probability of patients with solitary tumor without VI was 85%, that with multiple tumors without VI was 63%, that with solitary tumor with VI was 33% and that with multiple tumors with VI was 16%. The small tumor (&lt;5 cm) was another favorable factor which was significantly associated with CR. Among 231 patients without VI, the CR probability of patients with a solitary tumor &lt;5 cm or &gt;5 cm was 46% or 40%, respectively; although that of those with multiple tumors &lt;5cm or &gt;5cm was 21% or 5%, respectively. Conclusion: TACE is recommended for HCC patients without VI, and is optimally indicated for those with a solitary tumor or those with multiple tumor &lt;5 cm among them. No significant financial relationships to disclose.
The influence of fluticasone inhalation on premalignant lesions in the bronchial epithelium of a high risk population: A double blind placebo-controlled randomised phase II study
Authors: R. M. Van Den Berg, H. Van Tinteren, N. Van Zandwijk, T. G. Sutedja, P. Baas, C. Visser, K. Grünberg, W. J. Mooi, P. E. Postmus, E. F. Smit
Journal: Journal of Clinical Oncology (2006)

7200 Background: Bronchial epithelium exposed to cigarette smoke undergoes a series of histological changes that may ultimately lead to invasive cancer. In rats exposed to cigarette smoke inhaled corticosteroids reduce the number of lung tumors. We studied the effect of fluticasone on premalignant lesions in volunteers with a smoking history of ≥10 pack-years and patients cured of head and neck cancer or lung cancer. Methods: Participants were screened for premalignant lesions by bronchoscopy. At least 3 standard locations and suspicious lesions (if present) were biopsied. Use of systemic corticosteroids in the past 12 months or serious comorbidity precluded participation. Biopsies were classifed using WHO criteria. In case of a metaplasia index &gt; 15%, participants were randomised to receive a powder inhalation device containing either fluticasone 500 μg or a placebo. Compliance and side effects were monitored monthly. After 6 months, biopsies were taken from the same locations as previously sampled. Efficacy of treatment was assessed by reversal of metaplasia/dysplasia; secondary end-points were reversal of increased p53 immunoreactivity and hTERT expression. CT-scans were obtained at baseline and after intervention. Results: From February 2002 until October 2004, 201 subjects were screened. Two were excluded because of lung cancer detected during screening. Of the 108 volunteers included, 74 were male, mean age was 53 years (35–71), mean number of pack-years 48 (18–99), mean metaplasia index 48%, 32% had some degree of dysplasia at baseline. There were no significant differences between these characteristics in the intervention and placebo groups. Outcome: there was no significant difference with respect to reversal of metaplasia/dysplasia. Additional molecular studies will be performed to assess possible changes at a molecular level. Results will be presented at the ASCO annual meeting 2006. Conclusions: Fluticasone does not alter the natural course of premalignant lesions in the central airways when standard histological criteria are applied. No significant financial relationships to disclose.
Patterns of care and outcome of patients with gastroenteropancreatic neuroendocrine tumors (GNETs): Results from a Spanish multi-center hospital-based tumor registry
Authors: R. Garcia-Carbonero, E. Vilar, V. Alonso, M. Martínez del Prado, I. Sevilla, G. Crespo, A. Teulé, M. Llanos, D. Castellano, R. Salazar
Journal: Journal of Clinical Oncology (2007)

15110 Background: GNET represent an unusual family of neoplasms with a wide and complex spectrum of clinical behavior. To provide information regarding demographic characteristics, diagnostic procedures, tumor features, therapeutic interventions and outcomes of pts with GNETs, a national tumor registry was launched. We present here the results of this broad-based multi-institutional observational registry that comprises 41 sites representing all regions of Spain. Methods: Data was provided at www.retegep.net by participating centers and assessed for internal consistency by external independent reviewers. Results: The study cohort comprised 474 pts (57% male, median age: 59 years). 52% were carcinoids (C), 18% non-functioning pancreatic tumors (PT), 9% insulinomas and 6% gastrinomas. Most common primary tumor sites included midgut (19%), and head (14%) and body of the pancreas (9%). 10% were of unknown primary. Functioning symptoms led to diagnosis in 29% of cases. 5% were associated to MEN1. Diagnostic workup included serum hormone tests (60%), ultrasound (40%), CT scan (75%) and octreoscan (37%). 32% of pts presented with localized tumors (L), 14% with local-regional spread (LR) and 44% with advanced disease (Adv). Treatment for Adv disease consisted of somatostatin analogues (SA) (48%), surgery (45%), chemotherapy (CT) (42%), interferon (IFN) (23%), chemoembolization (9%) and radiofrequency ablation (5%). 5-year survival (5yS) for the whole group was 61.1% (SD:3.4%), 78.2% (SD:5.4%) for pts with L/LR disease and 47.1% (SD:5.6%) for Adv stages. 5yS rates were similar for C and PT tumors, also when stratifying according to tumor stage (84 and 76% for local-regional disease, and 51 and 49% for Adv disease). 1 st line systemic therapy (n=175) consisted of CT (42%), SA (39%), IFN (5%), SA+IFN (10%) and SA+CT (3%), with 5yS rates of 59%, 36%, 42%, 46% and 38%, respectively (p=0.7). As second line systemic treatment (n=65) 45% received CT, 26% SA, 15% immunotherapy and 14% different drug combinations. Conclusions: This national database reveals relevant information regarding current Spanish practices and will provide valuable insights into the epidemiology and management of this heterogeneous uncommon disease No significant financial relationships to disclose.
Excellent Prognosis of Children with ETV6-RUNX1 Positive (+) Acute Lymphoblastic Leukemia (ALL) in the FRALLE 2000 Protocol.
Authors: Virginie Gandemer, Marie-Françoise Auclerc, Arnaud Petit, Benoît Brethon, Paola Ballerini, Gerard Michel, Yves Perel, Anne Auvrignon, Francoise Mechinaud, Claudine Schmitt, Pascale Schneider, Christiane Vermylen, Odile Lejars, Thierry Leblanc, Jean Gabert, Elizabeth Macintyre, Jean-Michel Cayuela, Guy Leverger, Andre Baruchel
Journal: Blood (2009)
Tolerance and Efficacy of Argon Plasma Coagulation for Controlling Bleeding in Patients with Typical and Atypical Manifestations of Watermelon Stomach
Authors: S. Roman, J. Saurin, J. Dumortier, A. Perreira, G. Bernard, T. Ponchon
Journal: Endoscopy (2003)

Watermelon stomach is a well-known cause of gastrointestinal bleeding and anemia. This study investigated the efficacy of and patient tolerance for argon plasma coagulation (APC) in this condition.The reports of 21 patients with watermelon stomach who were treated using APC from February 1998 to August 2001 were reviewed. The efficacy of APC was evaluated on the basis of the patients' symptoms, transfusion requirements, and hemoglobin levels.Fifty-nine APC sessions were carried out (mean 2.81 sessions per patient, range one to five). Depending on the bleeding outcome and lesion intensity, repeat treatments were carried out with a mean delay of 1.8 months (range 2 days - 6 months). The mean follow-up period after the last session was 14.9 months (1 - 60.6 months). All of the patients required repeated blood transfusions before APC, compared with only two patients after treatment. One of these two patients died of uncontrolled bleeding despite APC. The mean hemoglobin level was 80.9 g/l before treatment, compared with 103.2 g/l after treatment. Three patients had recurrent bleeding 4.4 - 31.7 months (mean 13.8 months) after the last session and required a further session of APC, which controlled bleeding in all cases. Complications encountered consisted of two cases of hematemesis and one of sepsis.APC was effective in controlling bleeding due to watermelon stomach in the great majority of patients, with a low complication rate.
High-dose intensification therapy with autologous bone marrow support for limited small-cell bronchogenic carcinoma.
Authors: G Spitzer, P Farha, M Valdivieso, K Dicke, A Zander, L Vellekoop, W K Murphy, H M Dhingra, T Umsawasdi, D Chiuten
Journal: Journal of Clinical Oncology (1986)

The efficacy and toxicity of high-dose chemotherapy with autologous bone marrow transplantation (ABMT) was studied in 32 patients with untreated limited small-cell bronchogenic carcinoma (SCBC). Ten patients received three courses of induction therapy consisting of vincristine (VCR) (1.5 mg X 2), ifosfamide (5 g/m2), and Adriamycin (Ad; Adria Laboratories, Columbus, Ohio) (60 mg/m2). Patients then received two courses of intensification therapy with cyclophosphamide (CYT) (4.5 g/m2), 4' demethyl-epipodophyllotoxin-d-D-ethylidene glucoside (VP-16-213) (600 mg/m2) and VCR (2 mg) with ABMT. Another 22 patients received induction therapy with VCR, CYT (600 mg/m2), Ad (50 mg/m2), and VP-16-213 (180 mg/m2). All 22 patients also received intensification therapy of the same dose of CYT (4.5 g/m2) and VP-16-213 (600 mg/m2). Nine patients also received high-dose methotrexate (MTX), four patients received Ad (40 to 60 mg/m2), and two patients received both Ad and MTX. After intensification, patients received elective prophylactic brain irradiation (3,000 rad) and chest irradiation (5,000 rad). After induction therapy, there were 13 (41%) complete remissions (CR) and 17 (53%) partial remissions (PR). After intensification therapy, there were 22 CRs (69%) and 10 PRs (31%). Median survival for all patients was 14 months (range, 5 to 59+). Of the 13 patients who received intensification therapy in CR, five remain disease free (DF), four for 4 years or longer. Of the nine patients to achieve CR with intensification, only one is DF. No patient died during intensification. In conclusion, intensification with high-dose chemotherapy can increase the CR rate, and this approach is most likely to show long-term benefits in patients with minimal disease (CR) at the beginning of intensification therapy.
Characterization of triple-negative breast cancer utilizing microarray-based gene-expression profiling
Authors: M. Schmidt, B. Daniel, A. Lebrecht, H. Koelbl, J. G. Hengstler, M. Gehrmann
Journal: Journal of Clinical Oncology (2009)

e22014 Background: Triple-negative breast cancer (TNBC) is characterized by lack of expression of estrogen receptor (ER), progesterone receptor (PR) and HER-2. This makes it one of the most challenging subgroups for clinical decision-making. Methods: We analyzed gene-expression profiles of 200 node-negative breast cancer patients utilizing the Affymetrix HG-U133A array. After performing an unsupervised hierarchical cluster analysis using 2579 genes selected for variable expression within our dataset, we constructed metagenes for five dominant cluster (basal-like, luminal, proliferation, T-cell, B-cell). The interrelation of the median expression of these metagenes between TNBC and those cancer specimens expressing at least one of those receptors was analysed with the Wilcoxon-Mann-Whitney test. An intrinsic gene list was used to define basal-like breast cancer (BLBC). Sensitivity and specificity of TNBC to correctly classify BLBC was calculated. Metastasis-free survival (MFS) at 5 years was calculated according to Kaplan Meier. Results: Of the 200 node-negative breast cancer patients, 33 (16.5%) were triple-negative and 20 (10%) basal-like. Sensitivity of TNBC to correctly predict BLBC was 100%, specificity was 93.1%. TNBC showed an overexpression of the basal-like metagene (P=7.905e-13), an inverse relation with the luminal metagene (p=1.151e-12) and had higher proliferation and higher expression of T-cell (P=6.316e-5) and B-cell (P=3.551e-6) metagene. A higher expression of the B-cell metagene was associated with longer MFS in both TNBC (P=0.048) and BLBC (P=0.041). Conclusions: Characterization of TNBC reveals marked differences in gene-expression. Overexpression of mRNA transcripts related to the humoral immune system might serve as a protective factor in this particular subgroup. No significant financial relationships to disclose.