tbuckley/cabot-search huggingface dataset:
A phase I study of alternating chemotherapy with cisplatin/etoposide (PE) and irinotecan/amrubicine (IAm) in patients with small cell or non-small cell lung cancer
Authors: M. Ichiki, R. Fujiki, A. Shimada, T. Kamimura, K. Matsunaga, M. Hanada, T. Koga, H. Aizawa, S. Takamori
Journal: Journal of Clinical Oncology (2004)

7240 Background: Cisplatin (P) and etoposide (E) is most active regimen for small cell lung cancer (SCLC). Amurubicine (Am) is new single agent activity for ED-SCLC. We conducted a phase I study to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of this alternating regimen (PE: cycle 1, 3, 5, IAm: cycle 2, 4, 6) for patients with ED-SCLC and stage IV NSCLC. Methods: Eligibility criteria included: PS 0–2, age< 75 yrs, no prior therapy, measurable disease, adequate organ functions. Am(25–45 mg/m2) was given on day 1–3 in combination with Irinotecan (I) (70–90mg/m2, on day 1). P (60–80 mg/m2) was given on day 1 in combination with fixed dose E (100mg/m2, day1–3). Treatment was repeated every 3 weeks. DLT was defined as follows: 1) grade 4 neutropenia lasting 4 days or febrile neutropenia, 2) grade 4 thrombocytopenia, 3) prolongation of treatment due to toxicity, 4) grade 3 or worse non-hematological toxicity. Results: Three patients were enrolled at level I-1 (PE: 60/100, IAm: 70/25), 3 patients at level I-2 (PE: 60/100, IAm: 70/30) and 3 patients at level I-3 (PE: 60/100, IAm: 80/30), respectively. DLT was not observed at level I-1, 2, 3. Although four of five patients with SCLC achieved partial response (PR), only one of four patients with NSCLC achieved PR. Conclusions: MTD has not been reached yet and accrual is ongoing. No significant financial relationships to disclose.
Deliberate Self-harm Following Bariatric Surgery—Reply
Authors: Junaid A. Bhatti, Avery B. Nathens, Donald A. Redelmeier
Journal: JAMA Surgery (2016)

In Reply Morgan and Ho are concerned that media reporting of only relative increases in the risk of self-harm might mislead health policy makers and the public. We agree, and therefore provide actual counts, so that readers can judge absolute risks and the number needed to harm.1
Number of resected versus involved lymph-nodes as prognostic factor for survival and recurrence in early non-small cell lung cancer (NSCLC)
Authors: E. Bria, G. Alessandrini, I. Sperduti, M. Milella, F. Cuppone, P. Visca, D. Giannarelli, E. Terzoli, F. Cognetti, F. Facciolo
Journal: Journal of Clinical Oncology (2008)

7537 Background: Total number of resected lymph-nodes (TRN) has recently proven prognostic in early breast and colorectal cancer. However, its role, as well as that of involved nodes/TRN ratio (NR), in early NSCLC remains to be defined. To this purpose, we retrospectively analyzed a series of 415 consecutive, stage I-IIIA, NSCLC patients who underwent surgery at our institution. Methods: TRN and NR (continuous variables, significance cut-off <0.10) were correlated to clinical outcomes [overall- (OS), cancer-specific (CSS), and disease-free-survival (DFS)] using the Cox regression model, together with a panel of established clinical prognostic factors. Martingale Residual Plot analysis (MRP) was applied to assess the functional form of both variables; classification and regression tree (C&RT) and maximally selected log-rank statistic analyses were performed to find optimal cut-off values, in the presence of non-linear distribution of ratios. Results: Both TRN and NR were independent prognostic factors for OS, CSS, and DFS, together with sex and stage. Grading remained an independent factor only when TRN, but not NR, was included in the model. C&RT identified a TRN of 10 as the optimal cut-off (non-linear function at MRP). A NR of 9% was found to be the optimal cut-off in the node-positive subgroup (n=124). In this subgroup, NR remained an independent factor for OS (HR 2.02, 95% CI 1.17–3.49, p=0.01), CSS (HR 2.17, 95% CI 1.22–3.86, p=0.009), and DFS (HR 2.30, 95% CI 1.38–3.83, p=0.001). Conclusions: TRN and NR are powerful independent prognostic factors in early NSCLC undergoing curative surgery. Their routine use should be implemented in clinical practice and could help better defining subgroups of patients that benefit most from adjuvant chemotherapy. Overall (415 pts) TRN ≤ 10 > 10 p 3-yrs OS (%) 54.0 67.3 0.02 3-yrs CSS (%) 64.4 69.2 0.15 3-yrs DFS (%) 40.4 57.1 0.0005 Node-positive (124 pts) NR ≤ 9% > 9% p 3-yrs OS (%) 57.4 38.4 0.009 3-yrs CSS (%) 59.0 39.2 0.006 3-yrs DFS (%) 50.7 24.1 0.0008 No significant financial relationships to disclose.
Distribution of Blood Group Antigens A, B, H, and I(Ma) in Mucus-Producing Adenocarcinoma of Human Lung&lt;xref ref-type="fn" rid="FN2"&gt;2&lt;/xref&gt;
Authors: S Hirohashi, Y Ino, T Kodama, Y Shimosato
Journal: JNCI Journal of the National Cancer Institute (1984)

The distribution of blood group antigens A, B, and H and their precursor antigen I(Ma) in the mucus of lung cancer patients was studied histochemically. Antigens A, B, and H compatible with the ABO status of the patients were expressed in the mucus of bronchial gland mucous cells and bronchial goblet cells except in a few patients presumed to be nonsecretors , while antigen I(Ma) was not expressed at all in these cells. In contrast, compatible antigens A, B, and H were decreased or not present in cancer cells but antigen I(Ma) accumulated. Accumulation of antigen I(Ma), which resulted from incomplete synthesis of antigens A, B, and H, was a tumor-associated phenomenon in the mucus of the lung and was found in all patients examined. However, the degree of this accumulation varied from patient to patient, and tumor cells showed marked heterogeneity even in an individual case. In addition, accumulation of antigen associated with loss of antigens A and B was demonstrated in cancer cell mucus of patients with a blood group status other than O. Expression of incompatible blood group antigen reactive with anti-A serum (A-like antigen) also was detected in cancer cell mucus of blood group B patients.
Phase II study of bevacizumab (B) plus oxaliplatin (Ox) plus capecitabine (C) followed by bevacizumab (B) plus erlotinib (E) as first-line treatment in metastatic colorectal cancer (mCRC).
Authors: A. Muñoz, C. Pericay, B. Llorente, V. Alonso, R. Dueñas, J. Roca, F. Rivera, E. Falco, I. Alvarez, A. Salud
Journal: Journal of Clinical Oncology (2010)

3539 Background: A variety of combination therapies including 5-FU, Ox, Irinotecan, with or without new target agents are approved for patients (pts) with mCRC. The combination of B and E is being tested in different tumour types as well. Methods: Patients (pts) < 70 years old with mCRC, ECOG ≤ 1, measurable disease, adequate bone marrow, liver and renal function, no prior chemotherapy for mCRC and no evidence of brain metastasis or non-healing wounds or bone fractures were included. The efficacy and safety of the combination of 6 cycles of B (7.5 mg/kg iv [d1]), Ox (130 mg/m2 iv [d1]) and C (1,000 mg/m2 vo bid), all q3wk was assessed. If no progression, B (7.5 mg/kg iv) plus E (150 mg/d vo daily) was started until progression or unacceptable toxicity. The primary objective was: progression-free survival (PFS) and the secondary objectives: overall response rate (ORR), overall survival (OS) and toxicity profile. Results: 90 pts were included (61M; median age: 61 [r: 43-75]). The median of cycles administered was: B + Ox + C: 6 (r: 1-7) and B + E: 6 (r: 1-31). Among 89 evaluable pts for efficacy, ORR was observed in 47 (57%). The median PFS was 13.6 months (mo.) (95% CI, 10.2-15.8 mo.) and up to now median OS was 30.9 mo. (95% CI, 17.9-). Main grade 3/4 AEs (% of pts) related to treatment were: diarrhea (19%), asthenia (12%), neutropenia (8%), rash (7%), hypertension (4%) and vomiting, pulmonary embolism (PE) and deep vein thrombosis (DVT) in 3% of pts each. There were seven Grade 4 related-AEs: diarrhea, hypertension, PE, colitis ischemic, large intestine perforation, gastrointestinal toxicity and tumor perforation. Treatment discontinuation due to AEs was reported in 19 pts (22%). B specific AEs were very uncommon: hypertension in 3 pts, venous thromboembolic events, gastrointestinal perforation and fistula/intraabdominal abscess in 2 pts each, and proteinuria (1 pt). No treatment related deaths were reported. Conclusions: In conclusion, the combination of B + C + Ox followed by B+E significantly improves PFS in pts with mCRC with a good safety profile. This combination could offer a good opportunity as first-line treatment for this type of patients. No significant financial relationships to disclose.
A prospective study to evaluate the role of 2-[<sup>18</sup>f] fluoro-2-deoxy-d-glucose (FDG)-positron emission tomography (PET), breast magnetic resonance imaging (MRI), and breast ultrasonography in monitoring tumor responses in patients with locally advanced breast cancer (LABC) undergoing neoadjuvant chemotherapy.
Authors: S. D. Mukherjee, K. Dhamanaskar, R. Tozer, N. Hodgson, M. MacGillivray, C. Gu, K. Cline, L. Elavathil, J. Julian, K. Y. Gulenchyn
Journal: Journal of Clinical Oncology (2010)

595 Background: LABC is usually treated with chemotherapy followed by surgery and radiation. Monitoring of tumor response to chemotherapy occurs primarily with physical examination (PX). Newer imaging techniques such as PET and breast MRI may help to determine if the tumor is responding to chemotherapy. Methods: A prospective cohort study was conducted in women with LABC or inflammatory breast cancer. Patients underwent PX, US, MRI, and PET at baseline, midway, and at the end of chemotherapy. Mastectomy (M) was then performed. The primary outcome was each imaging test's ability to predict a pathologic complete response (pCR) following chemotherapy. Results: 49 patients were enrolled. Mean age was 50 (range 28-72). 92% had invasive ductal carcinoma. Patients were stage IIB (16%), IIIA (27%), IIIB (45%), IIIC (8%), and IV (4%). 38 patients had M. Seven (14%) patients achieved a pCR. Results for accuracy are shown in the Table. Patients achieving a pCR had a greater decrease in PET standard uptake value (SUV) compared to those without a pCR; mean decrease was 9.1 vs. 5.6, respectively (not statistically significant). Conclusions: Although our study was small, PET was the least predictive for pCR and MRI was the most sensitive and specific. A possible explanation for the low sensitivity with PET is that chemotherapy impacted on FDG uptake. Diagnostic test resultprior to surgery Pathology Estimator (95% CI) Tumor No Tumor Sensitivity Specificity PPV NPV PX Abnormal 19 0 0.76 1 1 0.50 Normal 6 6 (0.57, 0.89) (0.61, 1) (0.83, 1) (0.25, 0.75) US Abnormal 22 4 0.96 0 0.85 0 Normal 1 0 (0.79, 0.99) (0, 0.49) (0.66, 0.94) (0, 0.79) MRI Abnormal 18 1 0.90 0.80 0.95 0.67 Normal 2 4 (0.70, 0.97) (0.38, 0.96) (0.75, 0.99) (0.30, 0.90) PET Abnormal 8 2 0.36 0.60 0.80 0.18 Normal 14 3 (0.20, 0.57) (0.23, 0.88) (0.49, 0.94) (0.06, 0.41) No significant financial relationships to disclose.
Fertility preservation in breast cancer women undergoing adjuvant chemotherapy: A systematic review
Authors: M. R. Cruz, J. C. Prestes, M. F. Fanelli
Journal: Journal of Clinical Oncology (2008)

11568 Background: Breast cancer continues to be the most commonly diagnosed cancer in women. While breast cancer is more common in older women, about 1 in 200 women under the age of 40 is at risk to develop breast cancer. Among women who were treated for cancer, premature ovarian failure occurred in 17 percent at a mean age of 26 years and in 42 percent in the third decade, with an overall rate of premature ovarian failure of approximately 60 percent. Methods: We performed a literature search on Medline to identify trials that had investigated fertility preservation of young women exposed to adjuvant chemotherapy for breast cancer. Results: There is no published randomized controlled trial addressing this issue. There are two ongoing trials evaluating the role of ovarian suppression with GnRH-agonists in breast cancer women during chemotherapy. Data for fertility preservation in this setting of patients come from phase II and observational trials. The main methods of fertility preservation studied are ovarian protection by GnRH agonists, cryopreservation of operative sampled ovarian tissue or obtained fertilized or non-fertilized eggs after stimulation and puncture or embryos after in vitro fertilization. Conclusions: There are no evidence-based recommendations for preservation of fertility or ovarian function in breast cancer patients. Fertility preservation is an important issue for young breast cancer survivors and further studies should address this question. No significant financial relationships to disclose.
Medicinal Drugs of India.
Journal: JAMA (1930)

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Impact of Surgery Type and Co-Morbidities on Venous Thromboembolism prophylaxis Practices in Patients Undergoing Major Surgical Procedures in Acute Care Hospitals Worldwide: A Subanalysis of Data from the ENDORSE Survey
Authors: Ajay K Kakkar, Alexander T Cohen, Victor F Tapson, Jean-Francois Bergmann, Samuel Z. Goldhaber, Frederick A Anderson
Journal: Blood (2008)
Dose finding and pharmacokinetic study of an all-oral combination regimen of oral vinorelbine and capecitabine in metastatic breast cancer (MBC) patients: Final results
Authors: F. Nolè, C. Catania, G. Sanna, L. Adamoli, K. Imadalou, G. Zorza, A. Bodini, A. Goldhirsch
Journal: Journal of Clinical Oncology (2005)

666 Background: The study investigated oral vinorelbine (NBV oral) and Capecitabine (CAP) combination, which offers the convenience of an all-oral regimen. Methods: to determine maximal tolerated dose (MTD), recommended doses (RDs), safety, efficacy of the combination and to investigate potential drug-drug interaction. Forty-four patients (pts) with first (N=35) or second line (N=9) MBC entered the study. Three schedules were tested: NVB oral D1, D8/CAP D1-D14 every 3 weeks, NVB oral weekly/CAP D1-D14 every 3 weeks, and NVB oral D1, D8/CAP D1-D14 every 4 weeks. NVB oral was given at 60 mg/m2 or 80 mg/m2 with CAP from 1650 to 2500 mg/m2/d. Results: Median age 53.6 y (range; 31.6–73.8), 29 pts (65.9%) received prior (neo)adjuvant CT, 34 pts (77.3%) had visceral involvement and 29 pts (65.9%) had ≥ 2 organs involved. DLTs consisted in neutropenia resulting in delay in starting cycle 2 in 9 pts and febrile neutropenia (FN) in 2 pts. At 60 mg/m2, two RDs were established: NVB oral 60 mg/m2 weekly/CAP 2000 mg/m2/d D1-D14 q 3w and NVB oral 60 mg/m2 D1, D8/ CAP 2250 mg/m2/d D1-D14 q3w. At 80 mg/m2, the RD was NVB oral 80 mg/m2 D1, D8/CAP 2000 mg/m2/d D1-D14 q 4w. A total of 323 cycles were analyzed. Grade 3 occurred in 14 pts (31.8%) and 6.2% of cycles, grade 4 in 12 pts (27.3%) and 4.3% of cycles. Complications were rare, only 3 episodes of FN. No grade 4 non-haematological toxicity was seen. Grade 3 diarrhea occurred in 2 pts (4.5%) and 0.6% of cycles, no grade 3 HFS, grade 2 HFS occurred in 2 pts (4.5%) and 1.2% of cycles. A total of 18 responses were observed (3 CRs and 15 PRs) yielding a RR of 40.9% [95% CI: 26.3–56.8] in the ITT population. There was no mutual pharmacokinetic interaction when both drugs were co-administered. Conclusion: The combination of NVB oral and CAP is active and can be safely administered in the palliative setting of MBC. The phase II part of the study has started with NVB oral 60 mg/m2/week and CAP 2000 mg/m2/d from D1 to D14 every 3 weeks. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Institut de Recherche Pierre Fabre, Pierre Fabre
A randomized phase III trial comparing bexarotene/cisplatin/vinorelbine versus cisplatin/vinorelbine in chemotherapy-naive patients with advanced or metastatic non-small cell lung cancer (NSCLC)
Authors: J. Jassem, P. Zatloukal, R. Ramlau, P. O. Schwarzenberger, S. Orlov, J. Rodrigues-Pereira, G. J. Temperley, M. Mabry, A. Negro-Vilar, Z. Dziewanowska
Journal: Journal of Clinical Oncology (2005)

LBA7024 Background: Targretin (bexarotene) is a rexinoid that selectively activates RXR receptors which modulate functions associated with differentiation, inhibition of cell growth, apoptosis and metastasis. Data from four Phase I and Phase II studies suggests that combining bexarotene with chemotherapy in patients with first-line NSCLC may prolong survival. A randomized Phase III trial was performed to determine if adding bexarotene to cisplatin/vinorelbine chemotherapy prolongs survival of NSCLC patients. Methods: 623 chemo-naive NSCLC patients who had Stage IIIb disease with pleural effusion or Stage IV disease, who were performance status ECOG 0–1, and who had normalized triglyceride levels at study entry were enrolled. This study size will allow detection of a 30% survival improvement in the bexarotene treatment arm. Patients were stratified by disease stage and gender prior to randomization to bexarotene (400mg/m2/day) with cisplatin/vinorelbine or cisplatin/vinorelbine alone. Overall survival distribution (primary endpoint) between the arms will be analyzed by stratified log-rank test. Secondary endpoint is the one-year survival rate. Safety assessments were conducted. Efficacy and safety data will be mature and available in March, 2005. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Ligand Ligand Ligand Ligand
Lapatinib prevents the metastatic colonization of EGFR+ and Her-2+ breast cancer cells in the brain.
Authors: Brunilde Gril, Diane Palmieri, Eleazar Vega-Valle, Emily Hua, Jeanne Herring, Tona Gilmer, Stephen Rubin, Patricia Steeg
Journal: Cancer Research (2007)

4081  Central nervous system or brain metastases occur in 10-20% of metastatic breast cancer patients and are associated with a dire prognosis. The incidence of brain metastases appears to be higher in metastatic patients with Her-2 amplified tumors. We determined the efficacy of the dual EGFR/Her-2 tyrosine kinase inhibitor lapatinib on the brain metastatic colonization of a human breast carcinoma cell line. An EGFP labeled brain-seeking derivative of the human MDA-MB-231 cell line (231BR) endogenously overexpressed EGFR. When 231BR cells were transfected with a control vector or Her-2 cDNA, the Her-2 over expressing clones produced 2.5-3-fold greater large (>1.3mm2) metastases in the brains of Balb/c nude mice following intracardiac injection (p
Utility of hTERT-driven overexpression of E2F-1 to induce selective apoptosis of human breast cancer cells
Authors: M. A. Fanale, Y. Liu, S. Vorburger, T. McKenzie, S. Swisher, R. Theriault, K. Hunt
Journal: Journal of Clinical Oncology (2004)

3158 Background: The transcription factor E2F-1 normally induces cell cycle progression at the G1/S checkpoint, but when overexpressed will induce apoptosis. We have shown that CMV-driven overexpression of E2F-1 using an adenoviral vector (AdCMV-E2F-1) can induce apoptosis in multiple types of cancer cells independently of p53, p73 and caspases. We developed an adenoviral vector, AdhTERT-E2F-1, with E2F-1 under the control of the human telomerase reverse transcriptase (hTERT) promoter to minimize cytotoxicity to normal cells. We have shown that it induces apoptosis in colon cancer cells, and that its systemic delivery inhibits growth of liver metastasis in murine colon cancer models. Therefore, we wished to determine the ability of AdhTERT-E2F-1 to selectively induce apoptosis of breast cancer cells. Methods: Human breast cancer cells (MDA-MB-468) and immortalized breast epithelial cells (76NE6) were transfected (MOI of 2000) with AdhTERT-E2F-1, control vector AdhTERT-Luc, and mock transfected with PBS. Viable cells were counted at 24, 48, and 72 hours. At 72 hours apoptosis was measured by FACS, and protein was isolated from MDA-MB-468 transfected cells and subjected to a 10% SDS polyacrylamide gel electrophoresis and transferred to a nitrocellulose membrane. Membranes were incubated with antibodies against E2F-1, poly ADP-ribose polymerase (PARP), Apoptosis Inducing Factor (AIF), caspase-8, and β-actin. Results: MDA-MB-468 cells transfected with AdhTERT-E2F-1 demonstrated 50% growth inhibition and a 4.8-fold increase in apoptosis as compared to controls (AdhTERT-Luc, PBS). However, transfection of 76NE6 cells with AdhTERT-E2F-1 did not cause growth inhibition or apoptosis as compared to controls. Western blot analysis of MDA-MB-468 transfected with AdhTERT-E2F-1 showed E2F-1 overexpression, PARP cleavage (hallmark of apoptosis), and upregulation of caspase-independent AIF and caspase-8. Conclusions: These findings demonstrate that AdhTERT-E2F-1 can cause selective apoptosis of human breast cancer cells. Thus, we believe that AdhTERT-E2F-1 has promise for development in the treatment of metastatic breast cancer. No significant financial relationships to disclose.