Radiotherapy alone versus radiotherapy plus concomitant and post-radiotherapy temozolomide in newly diagnosed anaplastic astrocytoma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 12523-12523
Author(s):  
H. A. Elghazaly ◽  
S. A. Abdelkhalek
Keyword(s):  
Radiation Therapy ◽  
Anaplastic Astrocytoma ◽  
Malignant Gliomas ◽  
High Response Rate ◽  
Newly Diagnosed ◽  
Randomized Phase Ii ◽  
Significant Survival ◽  
Group A ◽  
Radiotherapy Alone ◽  
Group B

12523 Background: Malignant gliomas (glioblastoma multiforme and anaplastic astrocytoma) occur more frequently than other types of primary central nervous system tumors, having a combined incidence of 5–8/100,000 population. Even with aggressive treatment using surgery, radiation, and chemotherapy, median reported survival is less than 1 year. Temozolomide, a new drug, has shown promise in treating malignant gliomas. in this study we evaluate the value of adding temozolomide concomitantly with radiotherapy and for 6 cycles after in newly diagnosed anaplastic astrocytoma over radiotherapy alone. Methods: patients with newly diagnosed , histologically confirmed anaplastic astrocytoma were randomly assigned to receive, group A radiation therapy alone ( localized irradiation 60 Gy, fractionated 2 Gy / fraction, 5 fractions / week for 6 weeks) orgroup B radiation therapy alone ( localized irradiation 60 Gy, fractionated 2 Gy / fraction, 5 fractions / week for 6 weeks) plus temozolomide 200 mg per square meter daily for 5 days orally from the 1st day of radiotherapy to be repeated every 28 days for a total of 8 cycles ( 2 during radiotherapy and 6 after). The primary end point were overall survival and safety. Results: A total of 70 patients were randomized , with 35 in each treatment group. Median age was 41 years in group A and 43 years in group B. Surgical resection was complete in 5 % patients,partial resection in 88 % and stereotactic biopsy in 7% patients. In the temozolomide group median survival was 16.7 months and it was only 11.3 months in the radiotherapy alone group. Temozolomide was also associated with a high response rate 62%(CR 8.5% and PR 54.2 %) versus 37% in radiotherapy alone group with minimal additinal toxicity in the temozolomide arm. Conclusions: This randomized phase II trial suggest that temozolomid is effective and add statistically significant survival benefit over radiotherapy alone in newly diagnosed anaplastic astrocytoma with minimal toxicity. No significant financial relationships to disclose.

Randomized Phase II Study of Temozolomide and Radiotherapy Compared With Radiotherapy Alone in Newly Diagnosed Glioblastoma Multiforme

2005 ◽  
Vol 23 (10) ◽  
pp. 2372-2377 ◽  
Author(s):  
Helen Athanassiou ◽  
Maria Synodinou ◽  
Evagelos Maragoudakis ◽  
Mihalis Paraskevaidis ◽  
Cosmas Verigos ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Study ◽  
Malignant Gliomas ◽  
Progression Free Survival ◽  
Combined Modality Treatment ◽  
Newly Diagnosed ◽  
Randomized Phase Ii ◽  
Group A ◽  
One Year ◽  
Group B

Purpose Surgery remains the standard treatment for glioma, followed by radiotherapy (RT) with or without chemotherapy. Despite multidisciplinary approaches, the median survival time for patients with glioblastoma multiform (GBM) remains at less than 1 year from initial diagnosis. Temozolomide (TMZ), an oral alkylating agent, has shown promising activity in the treatment of malignant gliomas. We conducted a multicenter randomized phase II study comparing the efficacy and safety of TMZ administered concomitantly and sequentially to RT versus RT alone in patients with newly diagnosed GBM. Patients and Methods One hundred thirty patients with pathologically confirmed, newly diagnosed GBM were randomly assigned (110 assessable patients) to receive either TMZ 75 mg/m2/d orally, concomitantly with RT (60 Gy in 30 fractions; group A, n = 57), followed by six cycles of TMZ (150 mg/m2 on days 1 through 5 and 15 to 19 every 28 days), or RT alone (60 Gy in 30 fractions; group B, n = 53). Results Median time to progression was 10.8 months in group A and 5.2 months in group B (P = .0001). One-year progression-free survival rate was 36.6% in group A and 7.7% in group B. Median overall survival (OS) time was also significantly better in group A versus group B (13.4 v 7.7 months, respectively; P < .0001), as was the 1-year OS at 56.3% v 15.7% (P < .0001), respectively. Toxicity was mainly hematologic. One patient with grade 4 myelotoxicity died as a result of sepsis. The other side effects were mild. Conclusion TMZ combined with RT (concomitantly and sequentially) seems to be more effective than RT alone in patients with newly diagnosed GBM. The combined-modality treatment was well tolerated.

scholarly journals Clinical Outcome of an Multicentre, Randomized, Phase II Clinical Trial for Patients with Extranodal NK/T Cell Lymphoma Treated By P-Gemox or Aspametdex

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1569-1569 ◽  
Author(s):  
Hui-qiang Huang ◽  
Gao Yan ◽  
Hang Su ◽  
Yunhong Huang ◽  
Yuhuan Gao ◽  
...  
Keyword(s):  
T Cell ◽  
Progression Free Survival ◽  
Stage I ◽  
Stage Iii ◽  
Newly Diagnosed ◽  
Free Survival ◽  
Overall Response ◽  
Randomized Phase Ii ◽  
Group A ◽  
Group B

Intruduction Extranodal natural killer/T-cell lymphoma (ENKTL) is an uncommon, aggressive form of non-Hodgkin's lymphoma. Optimal therapeutic strategies have not been fully defined yet. Nasal NK/T-cell lymphomas present mostly with stage I/II disease. For stage I/II nasal lymphoma, a combination of chemotherapy and radiotherapy yields optimal results. Concomitant chemoradiotherapy and sequential chemotherapy and radiotherapy give similar response rates and survivals. For stage III/IV nasal, nonnasal, and disseminated ENKTL, systemic chemotherapy is indicated. Conventional anthracycline-based regimens are ineffective. Regimens containing L-asparaginase are most effective. Both AspaMetDex and P-Gemox is recommended as major effective combined chemotherapy regimen by NCCN guideline. Therefore, we try to evaluate the efficacy and toxicity for P-Gemox plus thalidomide and AspaMetDex followed by extensive involved field radiotherapy (EIFRT) as first-line treatment for newly diagnosed stage I/II patients and as salvage regimen for newly diagnosed stage III/IV or relapsed/refractory ENKTL in this clinical study. Methods We initiated a prospective, multicentre, randomized, phase II clinical trial at 12 centers in China at March 2014. Patients were randomly assigned to receive either P-Gemox+thalidomide regimen (Group A: Pegaspargase 2000U/m2; im d1, Gemcitabine 1000mg/m2; ivdrip , d1, d8. Oxaliplatin 130mg/m2; ivdrip, d1, thalidomide 100mg/d po, for one year.) or AspaMetDex regimen ( Group B: Pegaspargase 2000U/m2; im, d1, Methotrexate 3000mg/ m2; civ 6-hour, d1, calcium folinate 30mg iv, q6h, until reach safe serum MTX concentration, Dexamethasone 40mg/d ivdrip, d1-4.). For newly diagnosed stage I/II patients, both regimens were repeated every three weeks for a maximum four cycles as induction chemotherapy and followed by EIFRT at the dosage of 56Gy in 28 fractions over 4 weeks. Primary EIFRT was delivered using 6-MeV linear accelerator using 3-dimensional conformal treatment planning. For newly diagnosed stage III/IV or relapsed/refractory ENKTL, the regimens were repeated every three weeks for a maximum six cycles. Patients underwent autologous hematopoietic stem cell transplantation (ASCT) as consolidation if they achieved response (complete remission,CR or partial remission,PR). The primary endpoint was progression-free survival(PFS). Results Between March 2014 and March 2018, 165 patients were randomly assigned. 85 patients to Group A, 80 patients to Group B. 156 patients were evaluable for response. Investigator-assessed overall response at the end of induction was 88.2% in the Group A and 75.0% in the Group B. Complete remission (CR) rate were 60.0% and 55.0%. Among 107 newly diagnosed stage I/II patients, 54 patients were assigned to Group A (52 assessed), and 53 to Group B (47 assessed). Overall response during induction in Group A and B was similar in both groups, were 64.8% and 64.2%. 58 newly diagnosed stage III/IV or relapsed refractory patients were enrolled. 31 patients were assigned to Group A (30 assessed), and 27 to Group B. The efficacy rate of Group A was higher than that of Group B. Overall response rate were 87.1% and 66.6%, respectively. At median follow-up of 24.6 (1.0-60.9)months, 3-year progression-free survival (PFS) and overall survival (OS) of whole cohort were 61.4% and 63.4%. PFS and OS rate of Group A were similar to Group B(Figure 1). Group B was better tolerated than Group A, with lower rates of agranulocytosis, thrombocytopenia and infections. While anemia,hyperbilirubinemia, edema, and increased BUN/Cr were more common in Group B. Three patients died of treatment related toxicity only in Group B . Two patients died of severe acute renal failure and sepsis at the first cycle, and one patient died of sepsis at the third cycle. CONCLUSION: Induction chemotherapy of both P-Gemox+Thalidomide and AspaMetDex regimen followed by EIFRT yielded promising efficacy for patients with stage I/II ENKTL. There is little difference therapeutic effect between the two regimens. For advanced or relapsed patients, both regimen showed unsatisfied survival outcome. Meanwhile, P-Gemox+ Thalidomide was less toxic with more convenient administration in outpatients clinics in comparison to AspaMetDex. ( ClinicalTrials.gov, NCT 2085655 ). Disclosures Li: Guangdong Province Hospital: Employment.

Cisplatin, vinblastine, and mitoguazone chemotherapy for epidermoid and adenocarcinoma of the esophagus.

1987 ◽  
Vol 5 (8) ◽  
pp. 1143-1149 ◽  
Author(s):  
A A Forastiere ◽  
M Gennis ◽  
M B Orringer ◽  
F P Agha
Keyword(s):  
Pilot Trial ◽  
Transhiatal Esophagectomy ◽  
Newly Diagnosed ◽  
Surgical Specimen ◽  
Carcinoma Of The Esophagus ◽  
Group A ◽  
Tumor Measurements ◽  
Regional Disease ◽  
Group B

Thirty-six patients with adenocarcinoma or epidermoid carcinoma of the esophagus were entered into a phase II trial evaluating the combination of cisplatin 100 mg/m2 intravenously (IV) day 2, vinblastine 1.6 mg/m2 IV days 1 to 4, and mitoguazone (MGBG) 500 mg/m2 IV days 1 and 8. Twenty-nine patients (group A) were newly diagnosed with local-regional disease only and were candidates for transhiatal esophagectomy (THE). These patients received two courses of chemotherapy at 3-week intervals prior to surgery. Response was assessed by measuring changes in the primary tumor length and depth on serial biphasic contrast esophagrams and comparing this result with tumor measurements obtained from the surgical specimen. Complete (CR) and partial responders (PR) received three additional postoperative cycles. Seven patients had recurrent or metastatic disease (group B) and were treated every 4 weeks until disease progression. Of 34 patients evaluable for response, there was one pathologically confirmed CR and 15 PRs (47%). This consisted of 12 of 27 (44%) group A patients (seven of 11 epidermoid, five of 16 adenocarcinoma) and four of seven (57%) group B patients (two of four epidermoid, two of three adenocarcinoma). Toxicity included leukopenia in one third of treatment courses and thrombocytopenia in 21%. Nausea and vomiting occurred in 60% of patients, diarrhea in 18%, transient nephrotoxicity in 18%, peripheral neuropathy in 12%, and ototoxicity in 3%. Twenty-five group A patients underwent resection. Four chemotherapy nonresponders (NR) and one PR had known disease left at surgery; all others (80%) had gross total removal of their disease. The median survival time (MST) of the 29 group A patients was 14 months, with 21% alive at 36 months. The MST of group A chemotherapy responders was 15 months compared with 9 months for NRs (P = .032). Initial sites of recurrence in 14 patients were local-regional in six, distant only in six, both local-regional and distant in two. This regimen, administered in maximally tolerated doses, was active in epidermoid and adenocarcinoma histologies, recurrent disease and newly diagnosed patients. However, nearly all responses were PRs and the MST of resected patients was similar to a prior series of patients treated with esophagectomy alone. Observations from this pilot trial and those of others have led to a follow-up study, in progress, evaluating intensive preoperative chemotherapy and concurrent radiation therapy (RT).

scholarly journals Changes in Background Liver Function in Patients with Hepatocellular Carcinoma over 30 Years: Comparison of Child-Pugh Classification and Albumin Bilirubin Grade

Liver Cancer ◽  
2020 ◽  
Vol 9 (5) ◽  
pp. 518-528 ◽  
Author(s):  
Takashi Kumada ◽  
Hidenori Toyoda ◽  
Toshifumi Tada ◽  
Satoshi Yasuda ◽  
Junko Tanaka
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Function ◽  
Hepatic Function ◽  
Hepatic Reserve ◽  
Significant Survival ◽  
Detailed Evaluation ◽  
Group A ◽  
Group B ◽  
Survival Differences ◽  
Group D

Background: Background liver function in patients with hepatocellular carcinoma (HCC) has improved remarkably with advances in various treatments. Recently, the Child-Pugh classification (CPC) system has been recognized as limited in its ability to assess patients with good hepatic reserve. We compared the albumin-bilirubin (ALBI) grade, which is suitable for a more detailed evaluation of patients with good liver function, with CPC over a 30-year period. Methods: A total of 2,347 patients were analyzed. Patients were stratified by year of diagnosis into 6 groups: Group A (1990–1994, n = 376), Group B (1995–1999, n = 434), Group C (2000–2004, n = 438), Group D (2005–2009, n = 444), Group E (2010–2014, n = 392), and Group F (2015–2018, n = 263). We compared ALBI grade and CPC across the groups. Results: The prevalence of patients with CPC A at diagnosis increased throughout the study period, reaching nearly 80% in Groups E and F (p < 0.001). By contrast, the percentage of patients with ALBI grade 1 disease remained approximately 50% in Groups E and F (p < 0.001). Modified ALBI (mALBI) grade 2a corresponds to patients with CPC A who have poor hepatic function. There were significant survival differences between patients with mALBI grade 1 versus 2a, 1 versus 2b, and 2a versus 2b disease, respectively (p < 0.0001), in patients with CPC A. Conclusions: CPC is not suitable for assessing patients with recently diagnosed HCC and good remnant hepatic function. In such patients with HCC, the prognosis can be stratified by ALBI grade rather than CPC.

Chemotherapy of Brain Metastases from Lung Carcinoma: A Controlled Randomized Study

Neurosurgery ◽  
1991 ◽  
Vol 28 (2) ◽  
pp. 201-205 ◽  
Author(s):  
Yukitaka Ushio ◽  
Norio Arita ◽  
Toru Hayakawa ◽  
Heitaro Mogami ◽  
Hiroshi Hasegawa ◽  
...  
Keyword(s):  
Brain Metastasis ◽  
Brain Metastases ◽  
Lung Carcinoma ◽  
Tumor Regression ◽  
Randomized Study ◽  
Multidisciplinary Treatment ◽  
Group A ◽  
Radiotherapy Alone ◽  
The Difference ◽  
Group B

Abstract A controlled randomized study was carried out to evaluate the effects of chemotherapy in patients with brain metastases from lung carcinoma. One hundred patients were randomly divided into three groups at the time of diagnosis or after surgery for metastases. Group A received radiotherapy alone; Group B received radiotherapy and chloroethylnitrosoureas (methyl-CCNU, 100-120 mg/m2, or ACNU 80-100 mg/m2, every 6-8 weeks), and Group C received radiotherapy and a combination of chloroethylnitrosoureas and tegafur (300 mg/m2. daily). Of the 100 patients, 88 could be evaluated. The reduction rates of the tumors of the patients in whom tumor was not surgically removed or not totally removed were compared. Complete resolution of the tumor was noted in 29, 69, and 63% of the patients in Groups A, B, and C, respectively, Tumor regression of ⩾50% was seen in 36, 69. and 74% of the patients in Groups A, B, and C, respectively. The difference in the response rates of Groups A and C was statistically signficiant (P&lt;0.05). Median survival after the start of treatment for brain metastasis was 27, 30.5, and 29 weeks in Groups A, B, and C, respectively. There was 1 long-term survivor (more than 5 years) in Group A, 3 in Group B, and 1 in Group C. The main cause of death was deterioration attributable to the primary lesion or systemic metastasis, and no statistical difference was noted in survival time among the groups. Our results indicate that combination chemotherapy with chloroethylnitrosoureas and tegafur has an additive effect on radiotherapy in reducing or eliminating brain metastases from lung carcinoma, and that brain metastasis is well controlled by multidisciplinary treatment including chemotherapy.

scholarly journals NQPC-12 SHORT-TIME INTENSIVE REHABILITATION FOR PATIENTS WITH NEWLY DIAGNOSED MALIGNANT GLIOMAS WITH SPECIAL REFERENCE TO MEDICAL COOPERATION TEAM

2019 ◽  
Vol 1 (Supplement_2) ◽  
pp. ii31-ii31
Author(s):  
Takeshi Maeda ◽  
Masao Matsutani ◽  
Momoka Kato ◽  
Daijiro Okamura ◽  
Syoichi Muraya
Keyword(s):  
Radiation Therapy ◽  
Malignant Gliomas ◽  
Functional Independence ◽  
Rehabilitation Program ◽  
Maximum Point ◽  
Newly Diagnosed ◽  
Mri Imaging ◽  
Postoperative Radiation Therapy ◽  
Short Time ◽  
Intensive Rehabilitation

Abstract PURPOSE Many reports presented that patients with GBM had stable HRQoL during their remission time. However, there are few reports on the situation of ADL that is the basis of QOL. This prospective study was designed to evaluate the effectiveness of intensive rehabilitation for physically disabled patients with GBM after the initial treatment. PATIENTS and METHOD Twelve patients with newly-diagnosed glioblastoma presenting with severe physical disabilities were registered after the completion of postsurgical radiation therapy combined with TMZ. All patients were evaluated by means of a core set of clinical scales of Functional Independence Measure (FIM), Sitting Balance score, Standing Balance score, and Mini-mental State Examination (MMSE). Patients were evaluated before the beginning and at the end of rehabilitation treatment. The daily rehabilitation program consisted of individual 180-min. sessions of treatment, seven days a week, for four to six consecutive weeks. Speech therapy was included when aphasia was diagnosed. RESULTS Ten of 12 patients presented with mean increased FIM score of 26.6 points that reached the individual maximum point within 10 to 56 days. CONCLUSION A short-time intensive rehabilitation (4 to 6seeks) is effective for GBM patients during TMZ withdrawal period after the postoperative radiation therapy. This effective program requires close teamwork with the medical cooperation teams in the medical and rehabilitation hospitals: explanation to patients of the significance of the short-term rehabilitation, which is different from stroke rehabilitation, adjustment of hospitalization date considering radiotherapy and chemotherapy schedule, and adjustment of MRI imaging or bevacizumab administration schedule during rehabilitation.

Study on Gene Exppression Profiling Associated with Prognosis in AML (M2a).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4360-4360
Author(s):  
Fan Yi Meng ◽  
Jiaming Tang ◽  
Wenli Ma
Keyword(s):  
Bone Marrow ◽  
Complete Remission ◽  
Mononuclear Cells ◽  
Bone Marrow Mononuclear Cells ◽  
Oligonucleotide Microarrays ◽  
Newly Diagnosed ◽  
Standard Chemotherapy ◽  
Group A ◽  
Group B ◽  
Refractory Aml

Abstract Objective: to explore genes related to the prognosis of AML (M2a). Methods: 6 newly diagnosed AML were involved in this experiment and were divided into 2 groups. Group A: 3 AML (M2a) patients with continuous complete remission (CCR1) less than 6 months; Group B: 3 AML (M2a) patients with CCR1 more than 12 months. Bone marrow mononuclear cells were separated and mRNA was purified and labeled with Cy3 and Cy5 respectively, which were used to hybridize against the Agilent human 1B 60mer oligonucleotide microarrays. Results: in the 20173 genes tested, 22 genes were found to be expressed differently between these two groups, among them 10 genes were up-regulated in group A, and 12 genes were up-regulated in group B. Conclusion: with microarray assay, 22 genes including APP were found to be differently expressed in AML (M2a) treated with standard chemotherapy. These genes may be early indicators for the diagnosis as well as prognosis of the refractory AML.

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