tbuckley/cabot-search huggingface dataset:
Second-look hepatectomy after pharmacokinetic modulating chemotherapy (PMC) combination with hepatic arterial 5FU infusion and oral UFT in patients with unresectable hepatic colorectal metastases
Authors: M. Noda, H. Yanagi, R. Yoshikawa, T. Yamamura, M. Kusunoki
Journal: Journal of Clinical Oncology (2004)

3739 Background:In order to improve prognosis we carried out hepatectomy on patients with initially unresectable hepatic metastases, where the metastic lesions had shrunk and resection subsequently became possible (second-look hepatectomy: s-l hepatectomy) after neoadjuvant chemotherapy by HAI plus the oral anticancer drug UFT (pharmacokinetic modulating chemotherapy by HAI: HAI-PMC). Methods:Since 1993, 51 patients with unresectable hepatic metastases for colorectal carcinoma without extra hepatic diseases received HAI-PMC. The regimen of HAI-PMC is a combination of intra-arterial infusion of 5FU for 2 consecutive days per week at 600mg/m2/day and oral administration of UFT at 400 mg/day for 5 days per week for 6 months. Results:The response rate to HAI-PMC was 78.4%, but 6 months after starting HAI-PMC we judged thirty-one of the 51 patients(61%) to be cases where s-l hepatectomy was possible. Twenty-four of the 31 patients agreed to undergo s-l hepatectomy (A group) while 8 patients chose to go on HAI-PMC (B group). The two-year, three-year and five-year survival rates of patients in the A group were 84%, 58% and 42%, and for those in the B group, 62%, 25% and 0%. The survival rate of patients in the A group was significantly higher than for those the B group.(P=0.039) (median follow-up period, 42 months) Conclusions:These results indicate that there is no hope of a cure by chemotherapy for unresectable hepatic metastases, but that there is the possibility of a cure with s-l hepatectomy after HAI-PMC. No significant financial relationships to disclose.
Combination of Cytoreductive Therapies in Patients with Essential Thrombocythemia: A Preliminary Report From the E.X.E.L.S. Study.
Authors: Luigi Gugliotta, Carlos Besses, Martin Griesshammer, Claire N Harrison, Jean-Jacques Kiladjian, Ruth Coll, Jonathan Smith, Brihad Abhyankar, Gunnar Birgegård
Journal: Blood (2012)
Bi-weekly administration of pegylated liposomal doxorubicin plus paclitaxel in metastatic breast cancer (MBC) patients: A phase II study
Authors: E. Simoncini, V. D. Ferrari, V. Amoroso, F. Valcamonico, S. Grisanti, L. Vassalli, P. Marpicati, E. Montini, G. Rangoni, G. Marini
Journal: Journal of Clinical Oncology (2005)

844 The aim of this study was to evaluate the activity and safety of a dose-dense schedule of pegylated liposomal doxorubicin (Caelyx) and Paclitaxel (P). These chemotherapeutic drugs have different toxicity profiles and are not cross resistant. Chemotherapy was administered as follows: Caelyx 20mg/m2 infused over 1 hour on day 1, P 135 mg/m2 over 1 hour on day 1, repeated every 2 weeks. Inclusion criteria were: histologically confirmed diagnosis of MBC, at least one measurable lesion, adequate organ functions. Cardiac function was evaluated at regular intervals in all pts. From January 2003 to August 2004, 29 female pts were enrolled in the trial. Median age was 53 years (range 41–75), ECOG performance status was 0–1 in 25 pts (86%). Ten pts (34%) had HER-2 positive disease. Dominant metastatic site was visceral in 24 pts (82%); median number of metastatic sites was 2 (range 1–4). Previous treatments: adjuvant chemotherapy 71%; prior chemo for metastatic disease 25%; prior anthracyclines 44%; prior taxanes 22%. Pts. received a median of 7 cycles (range 4–10) for a total of 191 cycles administered. 28 patients were evaluated or toxicity, 27 for clinical response. Caelyx was initially given at 25 mg/m2 in the first 4 pts, while all other pts were treated at 20 mg/m2 because of grade 3 hand-foot syndromes in the first few pts. The most common adverse events were: hand-foot syndrome (grade 3 in 4 pts, grade 2 in 12 pts), grade 3–4 neutropenia in 10 pts, grade 3 anaemia in 1 pt. and grade 3–4 mucositis in 2 pts. Neither significant left ventricular ejection fraction decline, nor symptomatic cardiac event was observed. All pts received G-CSF support after grade 3–4 neutropenia. With a median follow-up of 10.1 months (2.8–20.0), response rate was 47% (95% CI: 26–68%) (3 CR, 10 PR), plus (5 MR, 5 SD). Bi-weekly Caelyx-P is an active and well tolerated regimen, even in anthracycline and taxane pre-treated pts, with no treatment-related death. Hand-foot syndrome was the most relevant adverse event. No significant financial relationships to disclose.
Anthracycline Adjuvant Chemotherapy: How Much Is Enough?
Authors: Mark N. Levine, Andrea Eisen
Journal: Journal of Clinical Oncology (2001)

Article Tools EDITORIAL Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2001.19.3.599 Journal of Clinical Oncology - published online before print September 21, 2016 PMID: 11157008 Anthracycline Adjuvant Chemotherapy: How Much Is Enough? Mark N. LevinexMark N. LevineSearch for articles by this author , Andrea EisenxAndrea EisenSearch for articles by this author Show More Cancer Care Ontario Hamilton Regional Cancer Centre, McMaster University, Hamilton, Ontario, Canada https://doi.org/10.1200/JCO.2001.19.3.599 First Page Full Text PDF Figures and Tables © 2001 by American Society of Clinical Oncology
Predictive and prognostic biomarker models in advanced lung cancer
Authors: S. Holdenrieder, D. Nagel, V. Heinemann, J. von Pawel, H. Raith, K. Feldmann, U. Stenman, P. Stieber
Journal: Journal of Clinical Oncology (2008)

19010 Background: Biomarker models may be effective for prediction of therapy response and prognosis of overall survival. Methods: 60 clinical factors, “classical” laboratory and oncological biomarkers were prospectively investigated on 300 patients with newly diagnosed advanced NSCLC before and during first-line chemotherapy to test whether i) predictive and prognostic markers are identical, ii) biomarkers have additive prognostic impact to clinical factors, iii) intratherapeutical biomarkers improve prognostic models, iv) biomarkers are useful for early estimation of therapy response? Univariate evaluations were done by Wilcoxon and Logrank tests, multivariate analyses by Cox regression. Results: 30% of patients had progression after 2 cycles of chemotherapy and 57% deceased during observation time (1–29 months). Concerning pretherapeutic markers, strong predictors of therapy response were also highly relevant for prognosis, such as performance score (PS), metastases other than lung (MOL), chemotherapy, WBC, CRP, albumin, CYFRA 21–1, nucleosomes, CA125, CA15–3, and CA72–4. Multivariate analysis revealed PS, MOL, chemotherapy, CRP and CYFRA 21–1 as independent prognostic parameters. When intratherapeutic markers were included, CYFRA 21–1 and nucleosomes before 2nd therapy cycle (BV2), and therapy response also indicated strongly and independently survival and improved the prognostic power of the model. Further, combination of nucleosomes on day 8 and CYFRA 21–1 (BV2) already enabled the detection of insufficient therapy efficacy after one cycle of chemotherapy in 29% of progressive patients with 100% specificity. At 90% specificity, sensitivity rose to 55%. Conclusion: In advanced lung cancer, highly predictive pretherapeutical biomarkers had also high prognostic relevance. Biomarkers determined during 1st therapy cycle improved the prognostic model and enabled the early estimation of therapy response. No significant financial relationships to disclose.
The prognostic value of testicular biopsy in childhood acute lymphoblastic leukemia: a report from the Childrens Cancer Study Group.
Authors: D R Miller, S L Leikin, V C Albo, N F Palmer, H N Sather, G D Hammond
Journal: Journal of Clinical Oncology (1990)

One of the objectives of Childrens Cancer Study Group (CCSG) study 141 (CCG-141) was to determine the frequency of occult testicular leukemia (TL) after 3 years of disease-free survival (DFS) and to retreat boys with occult TL to prolong their subsequent DFS. Of the 494 boys entered on study, 255 (51.6%) were in complete continuous remission (CCR) 3 years after entering remission and an additional eight were in CCR 3 years after localized extramedullary relapse and retreatment; 263 boys were eligible for testicular biopsy. Elective testicular biopsy was performed on 235 (89.4%) boys. Of the 204 (86.8%) boys with negative biopsies, 175 (85.8%) remained in CCR 10 to 12 years after diagnosis and 25 (12.3%) relapsed, 11 (44%) of whom died. Isolated overt TL occurred in four (2.0%) and all remained in CCR 22+ to 60+ months after re-treatment. Of the 26 boys with occult TL, 16 (62%) remained in CCR. Ten (38%) relapsed despite local testicular irradiation and systemic re-treatment; six of the 10 died. Of the 26 boys who did not undergo biopsy, 21 (80.8%) remained in CCR; two (7.7%) developed isolated overt TL. DFS after testicular biopsy was significantly better in boys without occult TL (P = .001). Occult TL after 3 years of CCR represents aggressive minimal-residual disease and carries a worse prognosis than absence of TL. Initial treatment should be directed at obviating occult and overt testicular relapse. Conventional therapy as used in this study was suboptimal in preventing subsequent bone marrow (BM) relapse and death. If occult TR is identified during or at the end of planned therapy, a higher salvage rate may require intensified alternate therapy. As such, testicular biopsies may be clinically useful. Further investigation is limited by the relative rarity of, and the lack of identifying features in boys with occult TL.
Antitumor Effects of Nonconjugated Murine Lym-2 and Human-Mouse Chimeric CLL-1 Monoclonal Antibodies Against Various Human Lymphoma Cell Lines In Vitro and In Vivo
Authors: Satoshi Funakoshi, Akio Hirano, Margaret Beckwith, Osamu Asai, Gitte Jorgensen, Zhi-gang Tian, Jason L. Hornick, Peisheng Hu, Leslie A. Khawli, Alan L. Epstein, Dan L. Longo, William J. Murphy
Journal: Blood (1997)
Phase II study of combined docetaxel, epirubicin, and cyclophosphamide as a neoadjuvant chemotherapy regimen in patients with locally advanced breast cancer in a single institution.
Authors: X. Yao, J. R. Hosenpud, C. R. Chitambar, J. A. Charlson, Y. Cheng
Journal: Journal of Clinical Oncology (2010)

e11040 Background: Neoadjuvant chemotherapy with anthracycline and taxane combinations is a standard approach for locally advanced breast cancer. One commonly used regimen is docetaxel, doxorubicin and cyclophosphamide. Epirubicin is another anthracycline used in breast cancer but the combined use of epirubicin and taxane is not well established. We conducted a single institution, phase II study to assess the efficacy of combined docetaxel, epirubicin and cyclophosphamide (TEC) as a neoadjuvant chemotherapy regimen. Methods: Eligible patients were female with newly diagnosed locally advanced breast cancer defined as T2 > 3 cm, T3-4, any N, or any T, N1-3, M0. A chemotherapy regimen of docetaxel 75 mg/m2, epirubicin 75 mg/m2 and cyclophosphamide 600 mg/m2 was given with growth factor support every 3 weeks for 6 cycles. All patients had surgery within 3-6 weeks after completion of chemotherapy. Primary end-point was pathologic complete response (pCR). Results: Twenty-one patients were registered from December 2003 to December 2006. One patient was excluded because of history of thyroid cancer. Median age was 51 (29-70). Eight patients (40%) were premenopausal. Ten patients (50%) had negative tumor hormone receptors. Four patients (20%) who had HER2/neu overexpression received adjuvant trastuzumab. All but one patient completed 6 cycles of TEC chemotherapy. One patient refused to receive the last cycle of chemotherapy. Fourteen patients (70%) had lumpectomy and 6 patients (30%) underwent mastectomy. The pCR rate was 25%. Eight of 16 patients with N1-3 disease (50%) had pathological negative lymph nodes. With a median follow up of 57.5 (16-71) months, 4 patients (20%) relapsed with 1 died from recurrence. The estimated 5-year relapse free survival is 79%. No patient had cardiac failure or death during treatment. The most common grade 3-4 toxicity was neutropenia (35%). Conclusions: Combined TEC regimen is a feasible, well-tolerated and effective neoadjuvant chemotherapy regimen for locally advanced breast cancer that results in a pCR rate of 25%. No significant financial relationships to disclose.
A Phase III Study of Cddp, Etop and Irinotecan Vs. Topotecan as 2Nd-Line Chemotherapy for Sensitive Relapsed Sclc: Jcog0605
Authors: Takashi Seto, Koichi Goto, Toshiaki Takahashi, Kazuhiko Nakagawa, Akira Yokoyama, Koji Takeda, Makoto Nishio, Kiyoshi Mori, Taro Shibata, Tomohide Tamura
Journal: Annals of Oncology (2014)
Utilization of radiation therapy in early-stage Hodgkin disease and its impact on survival
Authors: J. Rineer, D. Schreiber, A. Wortham, M. Olsheski, R. Sroufe, S. Sura, E. Katsoulakis, P. Han, K. Choi, M. Rotman
Journal: Journal of Clinical Oncology (2009)

8511 Background: Despite numerous randomized trials confirming the benefit of consolidation radiation therapy (RT) in the management of early stage Hodgkin disease (HD), utilization of RT in this setting remains variable. We performed a population-based analysis to assess the utilization of RT and its impact on overall and cause specific survival. Methods: The surveillance, epidemiology and end results (SEER) registry was used to identify patients aged 15–75 years diagnosed between 1990–2004 with early stage (stage I-IIA/B) HD, excluding nodular lymphocyte predominant HD. Kaplan-Meier analysis was performed to evaluate the effect of RT on overall survival (OS) and cause-specific survival (CSS). Subgroup survival analyses were also performed by era of treatment (1990–1997 and 1998–2004), sex, and patient age (&lt;30, 30–50, and &gt;50 years). Results: A total of 9729 patients met inclusion criteria. Median age of all patients was 34 years. The majority (71.3%) had nodular sclerosis (NS) type HD. By clinical stage, 3399 (34.9%) were stage I, and 6330 (65.1%) were stage II. 5352 patients (55%) received RT. RT was more likely to be employed during the early era of treatment, in younger patients, females, non-Blacks, and in NS, mixed cellularity and lymphocyte-rich HD. For the entire cohort, RT was associated with a significant (p&lt;0.001) improvement in OS and CSS (hazard ratio of 0.537 and 0.437, respectively). The benefit of RT for OS and CSS remained significant for all subgroups analyzed including the era of treatment, sex, and age (p≤0.001). Conclusions: In this large population-based series of early stage HD patients, the use of RT is associated with a significant OS and CSS benefit across all subgroups. Current efforts in clinical trials have aimed at decreasing the utilization of RT among this patient population. This shift in practice is reflected in the data presented here. The omission of RT from the treatment paradigm, however, appears to be related with diminished survival. No significant financial relationships to disclose.
Chemo-radiation dose intensity for patients with locally advanced non-small cell lung cancer (NSCLC), treated with split course radiation and concurrent vinorelbine (NVB) plus cisplatin (CDDP)
Authors: M. Dediu, A. Tarlea, A. Alexandru, D. Median, M. Radut
Journal: Journal of Clinical Oncology (2005)

7322 Background: Previous experience with concurrent chemo-radiation regimens at our institution showed a high rate of associated toxicities, which precludes the delivery of the whole protocol in a large fraction of patients (pts.). Methods: This prospective study was aimed to evaluate the efficacy and dose intensity (DI) of a split course radiation-therapy (RT) strategy, delivered concurrently with NVB and CDDP chemotherapy (CT). To be eligible, pts. had to have histologically or cytologically documented, locally advanced NSCLC, ECOG performance status(PS) 0–2. NVB 25 mg/m2 + CDDP 40 mg/ m2 on day 1+8 were administered in 4 cycles (days 1,8,22,29,57,64,78,85). Concurrent with the second CT cycle, RT (2 courses of 30 Gy separated by a 2 weeks break) was started, and was planned to achieve a total dose of 60 Gy (2 Gy/day/5 days /week). Results: From October 2000 to July 2004, 28 pts. were evaluated. Patients’ characteristics: males/females= 25/3, median age =61 years old, stage III B/III A = 25/3, ECOG PS 0–1=19 (68%) and PS 2= 9(32%), histology: adenocarcinoma/ squamous cell/ large cell/ unclassified 11/8 /1/8. Grade 3–4 toxicities : leucopenia 3 (11%), thrombocytopenia 1(4%), anemia 1(4%), esophagitis 3 (11%). The response rates were : 2 CR (7%), 12 PR (43%), 9 SD (32%) and 5 PD (18%), with an overall response rate of 50%. The estimated progression free and median survival was 9 and 12 months respectively. After a median follow-up of 11 months 19 pts (68%) relapsed, with 9 (32%) local and 10 (36%) distant failures. The sites of distant failures were : PUL 5(19%), OSS 2 (7%), BRA 2(7%), LYM 1(4%). Conclusions: Our concurrent schedule allows for good CT and RT dose intensities, with low associated toxicities. The pattern of relapses is equally divided between local and distant failures. Given the high proportion of pts. with stage IIIB and PS 2 status the survival data are promising. No significant financial relationships to disclose.
Subcutaneous (SC) dosing of recombinant human interleukin-21 (rIL-21) is safe and has clinical activity: Results from a dose-escalation study in stage 4 melanoma (MM) or renal cell cancer (RCC)
Authors: H. Schmidt, P. Selby, U. Mouritzen, U. H. Thelin, P. E. Kristjansen, P. Geertsen
Journal: Journal of Clinical Oncology (2008)

3041 Background: IL-21 plays a key role in cancer immunology, and rIL-21 administered IV and SC is currently in clinical trials as monotherapy and in various combinations. The maximum tolerated dose (MTD) for rIL-21 administered IV (thrice weekly or repeated 5-day cycles) was previously determined to be 30–50μg/kg. Here we report the outcome of a SC dose-finding study. Methods: A phase I, open label, dose escalation, safety and tolerability study of rIL-21 administered SC in patients with stage 4 MM or RCC. Primary objective: To assess safety and tolerability of escalating doses of rIL-21 using a 3/W dosing regimen, and to determine the SC MTD. Secondary objectives: dose-response relationship for selected biomarkers, pharmacokinetics, immunogenicity and effect on tumor size per RECIST. Eligible patients had histologically confirmed melanoma or RCC and surgically incurable stage 4 disease, PS 0–1, life expectancy > 3months, and no CNS involvement. rIL-21 was administered 3/W for 8 weeks, and pts without symptomatic progression after 8 weeks were offered an additional 8 weeks of treatment. Results: A total of 23 pts were included (11 RCC, 12 MM) at the following dose levels: 3, 10, 30, 100, 200, and 300μg/kg. No dose limiting toxicity was observed at any dose level, but the trial was stopped after inclusion of 7 pts at 300μg/kg due to inconveniently high SC injection volumes at higher doses. The safety profile was similar to but milder than what was observed in phase 1 studies of rIL-21 given IV. Typical adverse events were fever, malaise, rash, all grade 2 or less. Best tumor responses include 1 CR of 6 months duration (MM with cutaneous, lung and lymph node involvement treated at 10μg/kg) and 2 confirmed PR (RCC with abdominal mass and RCC with lung and mediastinal lymph node metastases both treated with 200μg/kg). Not all pts have been evaluated for response yet. Conclusions: rIL-21 can be safely administered in a 3/W regimen in doses up to and including 300μg/kg; a true MTD was not reached with the present drug formulation of 10mg/mL. To date clinically meaningful responses including 1 CR and 2 PR were observed among 23 pts exposed. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Novo Nordisk Novo Nordisk Novo Nordisk
A phase II trial of imatinib (IM) in relapsed, nonresectable chondrosarcoma (CS) expressing platelet-derived growth factor receptor-α or -β (PDGFR-α/PDGFR-β): An Italian Sarcoma Group study.
Authors: G. Grignani, E. Palmerini, S. Stacchiotti, A. Boglione, V. Ferraresi, S. Frustaci, A. Comandone, P. G. Casali, S. Ferrari, M. Aglietta
Journal: Journal of Clinical Oncology (2010)

10060 Background: CS is a rare and heterogeneous disease in which, after failure of surgery and radiotherapy, chemotherapy has a marginal role, if any. Different molecular pathways were shown to be activated in CS. Particularly, both PDGFR isoforms may be expressed and phosphorylated (PC Hogendoorn, MS Lagonigro). Since IM was proven effective in other sarcomas sharing the activation of this pathway, we investigated the activity of IM in advanced CS in a phase II trial. Methods: Between January 2007 and June 2009, 26 subjects, median age 61 (23-81), affected by metastatic, not resectable CS were treated with 400 mg of IM b.i.d. until progression or unacceptable toxicity. Eligibility criteria were: ≥1 prior line of chemotherapy, and immunohistochemical expression of either PDGFR-α or PDGFR-β . Primary objective was the percentage of patients free from progression at 4-month (Kaplan and Meier). Secondary objectives were: objective response (RECIST), overall survival, toxicity, clinical benefit (Pain Analgesic Score). Results: In all patients PDGFR was phosphorylated. Planned IM dose was delivered, but 60% (15) needed dose reductions due to manageable and short lasting toxicity [Median administered dose was 83% (74-91%) of full expected-one]. PFS at 4-month was 31% (2.6-7.8 months) (8). Median overall survival was 10.9 months. No objective responses, long lasting freedom from progression or improvement in PAS were observed. Conclusions: Imatinib, as expected, was relatively well tolerated, but it failed to show a meaningful clinical activity in term of both freedom from progression and tumor shrinkage. Advanced CS remains a disease not curable, and effective targeted therapies are still awaited. No significant financial relationships to disclose.