tbuckley/cabot-search huggingface dataset:
Clinical presentation and outcomes of adults with Burkitt and Burkitt-like lymphoma in Hong Kong
Authors: W. Li
Journal: Journal of Clinical Oncology (2008)

19544 Background: Burkitt and Burkitt-like lymphoma are highly aggressive neoplasms whose clinical course has not been well defined in the Hong Kong population. The management of these rare disorders is complicated by variable clinical presentation, multiple staging classifications and many different treatment options. At present, there have been no reported series on adult patients in Hong Kong. Methods: This is a descriptive study on a case series of twenty-five previously untreated patients with a diagnosis of Burkitt or Burkitt-like lymphoma. The study patients were collected retrospectively from two university hospitals from 1999 to 2006. Patients’ demographic, clinical, laboratory, chemotherapy regimens and survival data were analyzed. The Fisher exact test was used to compare the treatment toxicities and outcome between Stanford regimen and the modified CODOX-M/IVAC regimen. Results: The median age of the cohort was 52 with a median follow-up time of 19.7 months. Gastrointestinal (36%) and lymph node (28%) regions were the principle sites of involvement. At presentation 52% of the study patients had Ann Arbor stage IV disease, 28% had marrow and 16% had central nervous system (CNS) infiltration. Eight patients received Stanford regimen and twelve received modified CODOX-M/IVAC regimen. Patients on Stanford regimen experienced less grade 3–4 thrombocytopenia in comparison with patients on CODOX-M/IVAC regimen (P=0.019). The 1-year progression-free survival (PFS) and 1-year overall survival (OS) rate for the cohort was 60% and 68% respectively. The 1-year PFS for patients received Stanford and CODOX-M/IVAC regimens were 75% and 50% respectively (P =0.64) and the 1-year OS were 87.5% and 50% respectively (P=0.32). Conclusions: Burkitt and Burkitt-like lymphoma are rare among adult population in Hong Kong. Patients usually presented with an advanced stage of disease with bulky and widespread involvement. High complete remission and survival rate can be achieved even in patients with stage IV disease. The study demonstrated that the Stanford regimen is an effective and well tolerated protocol in the local Chinese population. No significant financial relationships to disclose.
A phase II trial of carboplatin and gemcitabine with exisulind (IND # 65,056) in patients with advanced non-small cell lung cancer: Eastern Cooperative Oncology Group Trial 1501
Authors: G. A. Masters, R. Xu, C. Langer, A. Dowlati, S. Madajewicz, D. H. Johnson
Journal: Journal of Clinical Oncology (2004)

7037 Background: The combination of carboplatin (CARB) and gemcitabine (GEM) is one standard regimen in advanced non-small cell lung cancer (NSCLC). The oral pro-apoptotic agent exisulind (EXI) has been shown to be well tolerated and safe, and may increase programmed tumor cell death. Methods: We studied this three drug combination on the following schedule: GEM (1000 mg/m2 days 1, 8) and CARB (AUC=5 day 1) q 21 days, with EXI given orally at 250 mg po BID on a continuous basis starting day 1 of therapy. The primary objective of this single arm phase II trial was to evaluate progression-free survival. Secondary objectives were to evaluate response rate, overall survival, and toxicities of the CARB-GEM regimen with EXI. Eligible pts had stage IIIB (malignant pleural effusion) or stage IV NSCLC with no prior chemotherapy and ECOG PS=0–2. Results: 58 pts were enrolled from October 2002 to February 2003 on this multi-institutional cooperative group study. There were 35 males and 22 females, 43 stage IV, 6 stage IIIB, and 9 with recurrent disease. The median age was 64 years (range 38–84). 26 pts had ECOG PS=0 and 32 had PS=1. The median number of cycles was 4. The principal grade 3–4 toxicities were hematologic (Table 1). Grade 3–4 non-hematologic toxicity seen in >5% of patients included: nausea 14%, and fatigue in 18% of patients. Among evaluable patients, 2 CR and 6 PR were observed for an overall RR of 17%. Median progression free survival was 4.7 months. Median overall survival was 7.1 months. Conclusions: In conclusion, GEM-CARB with the oral pro-apoptotic agent EXI is well tolerated with mainly hematologic toxicity. This regimen does not, however, show evidence of a benefit over standard chemotherapy and will be abandoned by ECOG for further study in NSCLC. Ongoing studies will evaluate its activity in other tumor types and stages. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly Eli Lilly Eli Lilly; Bristol-Myers Squibb
The efficacy of interferon-β and temozolomide combination therapy for newly diagnosed primary glioblatoma: Multicenter study.
Authors: K. Motomura, A. Natsume, M. Fujii, M. Ito, H. Namba, T. Abe, Y. Nakasu, R. Watanabe, K. Wakai, T. Wakabayashi
Journal: Journal of Clinical Oncology (2010)

2015 Background: Interferon-β (IFN-β) elicits pleiotropic biological effects such as antiproliferation, immunomodulation, and cell differentitative and has been widely used either alone or in combination with other antitumor agents in the treatment of malignant brain tumors. In this study, we evaluated the efficacy of IFN-β combined with standard of radiation (RT) and temozolomide (TMZ) for newly-diagnosed primary glioblastoma (GBM). Methods: This study included 54 consecutive patients with newly diagnosed primary GBM who underwent surgical treatment and received standard radiotherapy with concurrent TMZ at the standard Stupp regimen. Of total 54 patients, 27 patients (50%) received IFN-β in combination of TMZ. There were no significant differences in any of clinical parameters. Results: Median progression-free survival (PFS) and overall survival (OS) of all patients were 11.7 and 17.2 months, respectively. Multivariate analysis revealed methylated MGMT promoter (p= 0.005) and the combination of TMZ and IFN-β (p= .016) as independent prognostic factors associated with longer OS. Median OS of the combination group was significantly longer with 22.3 months (95% CI, 18.3 to 26.3) compared to TMZ alone group with 12.7 months (95% CI, 10.2 to 15.2). Notably, in even patients whose tumors had unmethylated MGMT promoter, median OS prolonged to 17.6 months (95%CI, 13.8 to 21.3) when receiving TMZ with IFN-β, compared to 12.7 months (95%CI, 11.7 to 13.7) in those receiving TMZ without IFN-β (p= 0.003). Furthermore in the subpopulation analysis of benefit from the use of IFN-β combination, there were significant associations with deep tumor location (p= 0.049), GTR negative (p= 0.030), ummethylated MGMT status (p= 0.018), and p53 mutation (p= 0.044). Conclusions: Addition of IFN-β to the standard regimen of TMZ and RT for newly diagnosed GBM showed promising efficacy. IFN-β and TMZ combination group achieved a favorable outcome, particularly in patients with unmethylated MGMT promoter. Survival data of unmethylated MGMT patients All patients TMZ with IFN-β TMZ without IFN-β Median OS (months) 15.1 17.6 12.7 12M-OS (%) 75 82 67 24M-OS (%) 23 33 11 No significant financial relationships to disclose.
SAFETY RESULTS FROM AVAglio, A PHASE III RANDOMIZED STUDY OF BEVACIZUMAB (BEV) PLUS STANDARD COMBINATION TEMOZOLOMIDE (TMZ) AND RADIOTHERAPY (RT) IN NEWLY DIAGNOSED GLIOBLASTOMA (GBM)
Authors: Frank Saran, Olivier L. Chinot, Roger Henriksson, Warren Mason, Wolfgang Wick, Ryo Nishikawa, Sunita Dahr, Magalie Hilton, Josep Garcia, Timothy Cloughesy
Journal: Neuro-Oncology (2013)

SAFETY RESULTS FROM AVAglio, A PHASE III RANDOMIZED STUDY OF BEVACIZUMAB (BEV) PLUS STANDARD COMBINATION TEMOZOLOMIDE (TMZ) AND RADIOTHERAPY (RT) IN NEWLY DIAGNOSED GLIOBLASTOMA (GBM)
A phase I/II trial of an allogeneic IL2-IFNγ-secreting tumor vaccine in patients with hormone refractory prostate cancer (HRPC)
Authors: H. Kübler, T. Brill, H. van Randenborgh, F. Fend, H. Pohla, D. Schendel, J. Breul, R. Paul, R. Hartung, B. Gänsbacher
Journal: Journal of Clinical Oncology (2005)

4748
Weekly high-dose 5-FU as a 24h-infusion and sodium folinic acid (AIO regimen) plus Irinotecan in patients with locally advanced non-resectable and metastatic adenocarcinoma or squamous epithelial carcinoma of the esophagus: Analysis of a phase II trial
Authors: F. Boxberger, K. Wolff, V. Brueckl, W. M. Brueckl, H. Albrecht, M. Engel, G. Maennlein, K. Mach, W. Hohenberger, E. G. Hahn, A. Wein
Journal: Journal of Clinical Oncology (2007)

15051 Background: In the majority of patients with esophageal carcinoma curative treatment proves to be impossible when establishing the diagnosis. While adenocarcinomas (ac) of the oesophago-gastric junction are increasingly treated in the same way as gastric carcinomas, the most frequently applied palliative chemotherapy regimen for both advanced squamous epithelial carcinomas (sec) of the oesophagus and gastric carcinomas is a combination of 5-FU and cisplatin. The question should be answered whether the AIO regimen plus irinotecan may achieve similarly positive results in esophageal carcinomas such as in gastric carcinomas (median survival (ms) up to 11 months). Methods: Prospective phase II trial, patients: n=25, trial start: 11/2002, chemotherapy: Irinotecan (80 mg/m 2 i.v. as 1h-infusion; d 1, 8, 15, 22, 29, 36, qd 57) as well as sodium folinic acid (500 mg/m 2 i.v.) together with 5-FU (2000 mg/m 2 i.v.; d 1, 8, 15, 22, 29, 36, qd 57) as 24h-infusion via a miniature pump system. Results: Last date of evaluation: 31/12/2006: n=25; ac: n=13, sec: n=12; UICC III: n=3, UICC IV: n =22; grading G1/G2/G3/G4: 0/10/10/5; median age: 58 (44- 77) years; men/women: 20/5; ECOG 0/1/2/3: 3/17/4/1; chemotherapeutic applications: 429. Evaluable in terms of toxicity: n=25. Higher grade toxicity: grade (g) III diarrhea: n=2, g III hyponatremia: n=1, g III stomatitis: n=1, g III fatigue: n=1, g III vomiting: n=1, g IV nausea: n=1, g IV elevation of creatinine: n=1, thrombosis of the vena subclavia: n=1, ischemic lesion of the brain stem: n=1. 4 patients died after 2 chemotherapeutic applications due to known peritoneal carcinomatosis and high tumour burden. Evaluable in terms of response: n=25. PR: n=7 (28%), SD: n=10 (40%), PD: n=2 (8%), not evaluable: n=6 (24%). Cases of death: n=18. Total ms: 13 months (95% CI 3,9–22,1). ms of ac: 20 months (95% CI 8,6–31,4). ms of sec: 8 months (95% CI 0,0–17). Secondary resection (R0): n=2. Conclusion: In oesophageal carcinomas the AIO regimen plus irinotecan is excellently manageable on an outpatient basis and shows high efficacy in both adenocarcinomas and squamous epithelial carcinomas of the oesophagus. No significant financial relationships to disclose.
Left thoraco-abdominal approach (LT) compared with abdominal and transhiatal approach (AT) for cardia or sub-cardia cancer. Results of a surgical randomized controlled trial (JCOG9502)
Authors: M. Sasako, T. Sano, M. Sairenji, K. Arai, T. Kinoshita, S. Yamamoto, N. Ishizuka
Journal: Journal of Clinical Oncology (2004)

4000 Background: It has long been controversial whether LT is superior to AT for two subtypes of esophago-gastric junctional (EGJ) tumors, true cardia (TC) and sub-cardia (SC) cancer. In many reports LT showed better survival but with increased morbidity. To evaluate the superiority of LT over AT, we conducted a RCT. Methods: Eligibility criteria included histologically proven adenocarcinoma, clinical T2–4 with esophageal invasion of 3 cm or less, 75 or younger age, no distant metastasis, sufficient organ functions for both procedures. Linitis plastica and stump cancer were excluded. Eligible patients were randomly assigned to either LT or AT before surgery. After curative surgery no adjuvant treatment was permitted until recurrence. Lymph nodes dissection included D2 dissection, left para-aortic nodes above renal vein for both arms but thorough or limited lower mediastinal dissection for LT and AT. The primary endpoint was overall survival. Postoperative morbidity, mortality and symptom scores were also evaluated. Projected sample size was 250 for alpha error one-sided 0.1, beta error 0.2 detecting 10% increase of 5-year survival. Results: The first planned interim analysis was performed at 12/03 using the information of 165 patients randomized between 07/95 and 10/03. The information time was 28%, O'Brien-Fleming type alpha-spending function was used. One patient died post-operatively after LT but none after AT. Higher morbidity was observed after LT as expected. The 3- and 5-year survival rates were 62% and 49% in the ATarm and 55% and 36% in the LT arm, respectively. Hazard ratio was 1.37 (95%CI: 0.84, 2.22) in favor of AT. One-sided stratified log-rank p was 0.93 (two-sided p 0.14). Conditional power that survival of LT would be significantly superior to that of AT at the end of the trial was estimated as 3.65%. The study was terminated immediately as JCOG Data and Safety Monitoring Committee recommended. Conclusions: This RCT demonstrated that LT has no survival benefit over AT for TC or SC with esophageal invasion of 3 cm or less. They should be treated by AT. No significant financial relationships to disclose.
Pemetrexed (P) in relapsed small cell lung cancer (SCLC): Preliminary results of a phase II trial
Authors: R. N. Raju, M. A. Neubauer, D. A. Smith, D. A. Richards, L. Asmar, J. L. Cunneen, R. Chen, D. F. Tai, C. K. Obasaju, M. A. Socinski
Journal: Journal of Clinical Oncology (2007)

7716 Background: Pts with relapsed SCLC have a poor prognosis and few effective treatment options. P is a novel multitargeted antifolate that is active and well-tolerated as a single agent in lung cancer. We undertook a trial to assess the efficacy and safety of single- agent P in both chemosensitive (S) and chemorefractory (R) relapsed SCLC pts. Methods: Eligible pts had limited or extensive- stage SCLC, PS 0 to 2, and only 1 prior chemo regimen. S pts were defined as having had a prior response with disease progression &gt;2 mos from end of 1st-line chemo. R pts were those who progressed while on 1st-line therapy, or had any response but progression &lt;2 mos from end of 1st-line chemo. The initial P dose tested was 500 mg/m 2 q 21 d. Planned sample sizes were 36 S pts in a 2-stage sequential fashion with potential early stopping for lack of efficacy or unacceptable toxicity, and 25 R pts in a single-stage design with no stopping rule. The stopping rule was invoked when &lt;3 of 14 qualified S pts responded. The protocol was then amended to evaluate P at 900 mg/m 2 in additional cohorts of 40 S and 40 R pts. Pts were to receive folic acid and Vitamin B 12 prior to treatment with P. The primary outcome measure was response rate. Results: From 7/04 to 3/06, 121 pts were enrolled, with 116 pts treated. S and R pts were analyzed separately at both dose levels. S pts (n=56): M/F, 29/27; median age 65 (range 43–82); PS 0/1/2, 25/23/8. R pts (n=65): M/F, 31/34; median age 64 (range, 35–85); PS 0/1/2, 16/37/12. *3 S pts treated with P 900 mg/m 2 remain with disease control after a minimum of 11 mos of follow-up. Conclusions: Preliminary clinical benefit rates (CR+PR+SD) of 20% and 17.4% achieved respectively in S and R pts treated with P 500 mg/m 2 suggest modest activity of single-agent P in relapsed SCLC. P can be given at a dose of 900 mg/m 2 without a significant increase in Grades 3–4 toxicities, although this does not appear to increase efficacy. [Table: see text] [Table: see text]
Third-line chemotherapy in metastatic breast cancer: A retrospective institutional assessment about clinical outcomes
Authors: F. M. Carcano, M. D. Gaui, L. P. Branco
Journal: Journal of Clinical Oncology (2009)

e17538 Background: Third-line chemotherapy in metastatic breast cancer (MBC) has been evaluated in phase II trials, but there were no prospective randomized studies showing clear benefit forward third-line chemotherapy. However, some patients increased their performance and quality of life despite short survival and low response rate. We analyzed the clinical outcomes in patients using third-line chemotherapy in MBC. Methods: 400 patients using chemotherapy from 2003 to 2007 were evaluated retrospectively. The overall survival (OS) and time to progression (TTP) were assessed with Kaplan-Meier method; the log rank test was applied to correlate known prognostic factors and third-line chemotherapy. Results: 122 patients received third line chemotherapy. The median age was 51 yrs, 89% had IDC histology, 45% had positive hormone receptor, 80% received taxanes or capecitabine as third-line chemotherapy, 88% had PS (ECOG) 0–1 or unknown, 55% had non-visceral metastasis, 89% had been previously exposed to anthracycline or taxanes, and 53% received more than three lines of chemotherapy. The median OS was 8.6 mo (95% CI; 7.5–10.3) and TTP one was 3.6 mo (95% CI; 2.8–4.5); 37% were alive in 1 yr, and the clinical response rate was 19%. TTP more than 8 mo in first- and/or second-line chemotherapy affected TTP in third line (5 vs. 3 mo; p = 0.003); only PS (ECOG) 0–1 resulted better OS (13 vs. 4 mo; p = 0.001). Conclusions: The OS and TTP found are similar to the literature and reflect the poor prognosis in patients receiving third-line chemotherapy in MBC. 8-month cut off TTP in previous lines determine the TTP in third line and good PS results better OS. No significant financial relationships to disclose.
Substitute “Prostate Cancer” for “Neuroblastoma”?
Authors: William G. Woods
Journal: Journal of Clinical Oncology (2002)

Article Tools EDITORIALS Article Tools OPTIONS & TOOLS Export Citation Track Citation Add To Favorites Rights & Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2002.20.5.1154 Journal of Clinical Oncology - published online before print September 21, 2016 PMID: 11870152 Substitute “Prostate Cancer” for “Neuroblastoma”? William G. WoodsxWilliam G. WoodsSearch for articles by this author Show More AFLAC Cancer Center, Emory University/Children’s Healthcare of Atlanta, Atlanta, GA https://doi.org/10.1200/JCO.2002.20.5.1154 Full Text PDF Figures and Tables "Substitute “Prostate Cancer” for “Neuroblastoma”?." Journal of Clinical Oncology, 20(5), pp. 1154–1155© 2002 by American Society of Clinical Oncology
Phase I study of bortezomib and oxaliplatin (BOX) in solid tumors: Improved neurotoxicity (NT) profile with lower bortezomib (B) dose
Authors: R. A. Kosloff, J. Wright, P. Ivy, J. Escalon, B. Norwood, B. Levinson, A. C. Pavlick, A. Beric, F. M. Muggia, H. Hochster
Journal: Journal of Clinical Oncology (2006)

12007 Background: B inhibits proteasome function and may be synergistic in causing apoptotic death with platinum agents. We were interested in combining B with OX but concerned with dose limiting (DL) NT based on our prior B phase I study [Hamilton et al., JCO 2005]: therefore this Phase I dose-escalation study (alternating increases of B and OX) focusing on NT was planned. Methods: Patients (pts) with metastatic solid tumors, PS 0–2, platinum or taxane naive, no peripheral neuropathy and adequate organ function, received B (D1, 4, 15, 18) and OX (D1, 15) every 28 days in a dose escalation design (see table ). Baseline and monthly assessments were performed by an independent neurologist. Results: 27 (18 gastrointestinal, 3 melanoma, 3 ovarian, 3 others) were accrued; pt characteristics: 14 male/13 female; median age 55 years (range 35–75); 2 median cycles (range 1–10). NT was not DL because it did not occur within the first cycle. Late and limiting NT was observed in levels 2–5 after 2–9 cycles, but serial neurologic evaluations showed reversible NT. With an amended new dose level to lower B to 1.0 mg/m 2 (level 6) to avoid late NT, NT was not observed. Of 22 evaluable pts, there were 3 partial responses (ampullary, GE junction, biliary), 6 stable disease, and 13 disease progression by RECIST criteria. Conclusions: biweekly BOX is tolerable at B 1.0 mg/m 2 and OX 85 mg/m 2 with no DL NT. Additional observations on late NT are ongoing. This suggests B is a major contributor to NT observed in dose levels 2–5 and may potentiate the effects of OX. [Table: see text] [Table: see text]
Phase II trial of 4 cycles dose dense docetaxel (D) 100mg/m2 every 2 weeks with G-CSF support, followed by 3 cycles of 5-fluorouracil (F), epirubicin (E) and cyclophosphamide (C) every 3 weeks as neoadjuvant treatment of operable > 2cm breast cancer
Authors: G. Romieu, F. Bibeau, S. Culine, S. Gourgou-Bourgade, C. Guillemare, A. Kramar
Journal: Journal of Clinical Oncology (2006)

10636 Background: Docetaxel is one of the most active chemotherapy agents used in breast cancer. Given the effectiveness of Taxotere in the treatment of metastatic breast cancer, it is now being extensively evaluated in the treatment of early stage disease. Recently, we initiated in our institution a study, which showed that the bi-weekly administration of 4 cycles of docetaxel was feasible with G-CSF (lenograstim) support. This phase II trial was initiated to evaluate the pCR rate of docetaxel as a single agent followed by FEC 100 in the neoadjuvant setting. Methods: Eligible patients (pts) with histologically proven breast cancer, measurable lesions &gt;2 cm were scheduled to receive 4 cycles of chemotherapy with a day 1 bolus of (D) 100 mg/m 2 every 14 days + corticoids for 3 days starting the day before first infusion as premedication and primary prophylaxis with G-CSF: followed by 3 cycles of a continuous infusion of F 500 mg/m 2 , E 100 mg/m 2 and C 500 mg/m 2 day 1 (FEC100). The primary endpoint was the pCR rate using the classification of Sataloff. Results: From 12/2003 to 12/2004, we treated 45 pts with median age 45 [25–63]. To date, 43 pts with WHO PS 0 were evaluable with T2: 22, T3: 19, T4: 2 pts and 18/21/5/1 N0/N1/N2/N3. Among 43 eligible pts, 2 stopped because of toxicity (after the 2nd and 4th cycles) and 1 patient refused to continue after 3 cycles. During the first treatment sequence with D, grade 3–4 toxicities (%pts): neutropenia (13), grade 3: cutaneous (24), myalgies (4), and arthalgies (2), and grade 2 neurotoxicity (31). During the second treatment sequence with FEC, grade 3–4 toxicities (% pts) were: neutropenia (95), grade 3: thrombocytopenia (5), myalgies (2), mucitis (2), grade 2 neurotoxicity (24). The conservative surgery rate was 67% and 3 pts needed a secondary mastectomy. The pCR rate was 50% (95% CI 34%– 66%) (26% T-A) among 42 evaluable pts. Conclusion: This regimen allows conservative surgery in more than half of all patients and we conclude from these findings that 4 cycles of dose-dense D followed by 3 cycles of FEC is an active induction regimen with a tolerable toxicity profile. No significant financial relationships to disclose.