Intracarotid Chemotherapy with a Combination of 1,3-Bis(2-chloroethyl)-1-nitrosourea (BCNU), cis-Diaminedichloroplatinum (Cisplatin), and 4'-O-Demethyl-1-O-(4,6-O-2-thenylidene-β-D-glucopyranosyl)epipodophyllotoxin (VM-26) in the Treatment of Primary and Metastatic Brain Tumors

Neurosurgery ◽  
1984 ◽  
Vol 15 (6) ◽  
pp. 828-833 ◽  
Author(s):  
J.Stewart David ◽  
Zvonimir Grahovac ◽  
Brien Benoit ◽  
David Addison ◽  
Michael T. Richard ◽  
...  
Keyword(s):  
Brain Tumors ◽  
Vertebral Artery ◽  
Response Rate ◽  
Drug Regimen ◽  
Cranial Irradiation ◽  
Severe Toxicity ◽  
Intraarterial Infusion ◽  
Computed Tomographic ◽  
Heavily Pretreated ◽  
Previously Treated

Abstract Thirty-seven patients with intracranial primary or metastatic tumors were treated with an intraarterial combination of BCNU, cisplatin, and VM-26 to determine the efficacy, toxicity, and maximal tolerated doses for the combination. A transfemoral fluoroscopic approach was used to catheterize temporarily the internal carotid or vertebral artery. Thirteen of 19 (68%) evaluable primary brain tumors and 9 of 16 (56%) evaluable brain metastases responded. The response rate was lower in patients previously treated with both cranial irradiation and i.v. chemotherapy than in patients less heavily pretreated (54% vs. 82%), although even patients previously treated i.v. with all three of the study drugs responded. All five patients with both extracranial and intracranial evaluable tumor deposits experienced a greater response of their intracranial than of their extracranial tumor. Ipsilateral retinal and neurological toxicity were dose-limiting, with major toxicity (permanent decreased vision or hemiparesis) occurring in five of nine (56%) patients receiving doses of BCNU ≥ 100 mg/m2, plus cisplatin, 60 mg/m2, plus VM-26, 175 mg/m2. Only 9% of the patients treated with a lower VM-26 dose developed permanent severe toxicity, and the doses that we now recommend are: BCNU, 100 mg/m2; cisplatin, 60 mg/m2; and VM-26, 150 mg/m2. The response rate was also dose-related (100% at the highest doses tested vs. 57% at the lower doses). Fully reversible toxicity was also seen, including transient decrease in ipsilateral visual acuity (11%), transient hemiparesis or hemianesthesia (5%), transient increased intracranial pressure (5%), mild ototoxicity (3%), mild to moderate vomiting (80%), severe periorbital pain and erythema during BCNU infusion (94%), and myelosuppression (30%). Vertebral artery infusion must be performed with great caution because infusions of BCNU and VM-26 (but not of cisplatin) were associated with marked but rapidly reversible somnolence and potentially life-threatening cardiac and respiratory depression. No cardiorespiratory depression was seen with carotid artery infusions. The intraarterial infusion of this three-drug regimen is quite effective in reducing the size of the tumor as seen on the computed tomographic scan in this poor prognosis group of patients, but is also potentially quite toxic. We are now initiating other studies adding i.v. drugs to our intracarotid combination.

Salvage chemotherapy with paclitaxel for recurrent primary brain tumors.

1995 ◽  
Vol 13 (8) ◽  
pp. 2066-2071 ◽  
Author(s):  
M C Chamberlain ◽  
P Kormanik
Keyword(s):  
Brain Tumors ◽  
Blood Product ◽  
Young Patients ◽  
Salvage Chemotherapy ◽  
Subtotal Resection ◽  
Primary Brain Tumors ◽  
Cell Counts ◽  
Heavily Pretreated ◽  
Previously Treated ◽  
Time To Tumor Progression

PURPOSE To assess the safety and efficacy of Taxol (paclitaxel; Bristol-Myers Squibb Co, Princeton, NJ) given at a dose of 175 mg/m2 every 3 weeks as a 3- to 4-hour outpatient infusion to patients with recurrent malignant primary brain tumors who had received prior radiotherapy and at least one chemotherapy regimen containing nitrosoureas and who were no longer responding to therapy. PATIENTS AND METHODS Twenty patients (12 men and eight women), ages 19 to 69 years (median, 35), with recurrent primary brain tumors were treated according to a phase II protocol with intravenous Taxol. Tumor histologies included the following: anaplastic astrocytoma (n = 8), glioblastoma multiforme (n = 8), and anaplastic oligodendroglioma (n = 4). All patients had been previously treated with subtotal resection, limited-field radiotherapy (median dose, 60 Gy; range, 54 to 78 Gy), and nitrosourea-based chemotherapy. Taxol was administered intravenously at a dose of 175 mg/m2/d every 3 weeks with neurologic and neuroradiographic evaluation every 8 to 9 weeks. Complete blood cell counts were performed weekly. RESULTS A median of six cycles of Taxol (range, two to 12) were administered to 20 assessable patients. Toxicities included partial alopecia (n = 10), thrombocytopenia (n = 4), rate of Taxol administration-dependent bradycardia (n = 3), and nondisabling peripheral neuropathy (n = 1). No patient developed neutropenic fever or sepsis or required cytokine support. Two patients required blood-product support (platelet transfusions in both). Four patients (20%) demonstrated a partial response (PR) and seven (35%) had stable disease (SD) for a total response plus SD rate of 55%. The median time to tumor progression was 6 months (range, 2 to 20). CONCLUSION Taxol demonstrated modest efficacy with minimal toxicity in this heavily pretreated cohort of young patients with recurrent primary brain tumors.

Lenalidomide (Revlimid), Bortezomib (Velcade) and Dexamethasone (RVD) for Heavily Pretreated Relapsed or Refractory Multiple Myeloma

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 5028-5028
Author(s):  
Victor H Jimenez-Zepeda ◽  
Donna E. Reece ◽  
Suzanne Trudel ◽  
Christine Chen ◽  
Ahmed M. Rabea ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Research Funding ◽  
Response Rate ◽  
Treated Patient ◽  
Median Number ◽  
Disease Stage ◽  
Vein Thrombosis ◽  
Duration Of Response ◽  
Heavily Pretreated ◽  
Previously Treated

Abstract Abstract 5028 Lenalidomide (len) and bortezomib (btz) are active in multiple myeloma (MM). In preclinical studies, lenalidomide sensitized MM cells to bortezomib and dexamethasone (Mitsiades N, et al). The combination of lenalidomide (Revlimid), bortezomib (velcade), and dexamethasone (RVD) has shown excellent efficacy in relapsed/refractory (rel/ref) multiple myeloma (MM) patients (pts), with an overall response rate (ORR) of 84% and a partial response (PR) rate of 68%, including 21% complete/near complete responses (CR/nCR), median duration of response was 24 weeks in responding patients and median number of cycles was 6 (Anderson KC, et al. ASCO 2009: abstract 8536). The aim of this study is to assess the efficacy and toxicity profile when len is used in combination with btz and dexamethasone (dex) for pts with relapsed/refractory (rel/ref) disease outside the setting of clinical trials. Patients and Methods We retrospectively reviewed the records of all pts with rel/ref MM who were treated with RVD at Princess Margaret Hospital between March 2009 and March 2010. Eighteen pts were treated with at least 1 full cycle of RVD therapy given as len 10 mg/d on days 1–14, btz 1.0 or 1.3 mg/m2 on days 1, 4, 8, and 11 of 21-day cycles and dex (20 mg or 40 mg on days of and after btz). Pts routinely received concomitant antithrombotic and antiviral prophylaxis. Primary endpoints were response rate, time to progression (TTP) and toxicity. Responses were assessed according to modified EBMT and Uniform criteria. Toxicity was assessed using NCI-CTC, version 3.0. Results Clinical characteristics are seen in Table 1. Median age was 57 (37-71) years; 55% were female. The median number of prior therapies was 3 (2-6), and the majority of pts had already been treated with len (83%) and btz (78%) separately, and 77% had received both drugs previously but not in combination. In many instances, pts previously treated with len had len added to btz + dex at progression (n=5), or pts previously treated with btz had btz added to len + dex, at progression (n=4). After a median of 4.9 cycles (range 1–14), PR was observed in 7 (39%) and stable disease (SD) in 2 (11%) pts, for an ORR of 39%. Disease progression was seen in 14 pts at a median TTP of 4 months (1-13.6 months). Currently, 6 pts (33%) remain alive at a median F/U of 6.83 months (1.4-18.6 months). Median overall survival was 6.88 months (1-18.6 months) and six patients had a greater than 6 month response. Six pts have experienced grade 3/4 adverse events, including anemia, neutropenia, muscle weakness, hyperglycemia, and pneumonia. No deep vein thrombosis was observed. The side effect profile was manageable; importantly no patient experienced worsening of peripheral neuropathy. Conclusions The ORR for our heavily treated patient population was 39% which is lower than that reported by Anderson et al (ASCO, 2009). The median TTP was also short at 4 months. These differences can be partly explained by the fact the majority of our pts had previously received all the agents in RVD, while only 8% of the pts in the Anderson series had prior len exposure. These data suggest that the RVD combination can be effective in rel/ref MM, but responses/duration are affected by very advanced disease stage at relapse and the extent of prior treatment. Disclosures: Reece: Celgene: Honoraria, Research Funding. Chen:Celgene Corporation: Consultancy, Honoraria, Research Funding. Kukreti:Celgene: Honoraria.

Phase II Study of Eribulin Mesylate, a Halichondrin B Analog, in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane

2009 ◽  
Vol 27 (18) ◽  
pp. 2954-2961 ◽  
Author(s):  
Linda T. Vahdat ◽  
Brian Pruitt ◽  
Carol J. Fabian ◽  
Ragene R. Rivera ◽  
David A. Smith ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Response Rate ◽  
Phase Ii Study ◽  
Metastatic Breast ◽  
Eribulin Mesylate ◽  
Halichondrin B ◽  
Heavily Pretreated ◽  
Pretreated Patients ◽  
Previously Treated

Purpose Eribulin mesylate (E7389), a nontaxane microtubule dynamics inhibitor, is a structurally simplified, synthetic analog of the marine natural product halichondrin B. This open-label, single-arm, phase II study evaluated efficacy and tolerability of eribulin in heavily pretreated patients with metastatic breast cancer (MBC). Methods MBC patients who were previously treated with an anthracycline and a taxane received eribulin mesylate (1.4 mg/m2) as a 2- to 5-minute intravenous (IV) infusion on days 1, 8, and 15 of a 28-day cycle. Because of neutropenia (at day 15), an alternative regimen of eribulin on days 1 and 8 of a 21-day cycle was administered. The primary end point was overall response rate. Results Of the 103 patients treated, the median number of prior chemotherapy regimens was four (range, one to 11 regimens). In the per-protocol population (n = 87), eribulin achieved an independently reviewed objective response rate (all partial responses [PRs]) of 11.5% (95% CI, 5.7 to 20.1) and a clinical benefit rate (PR plus stable disease ≥ 6 months) of 17.2% (95% CI, 10.0 to 26.8). The median duration of response was 171 days (5.6 months; range, 44 to 363 days), the median progression-free survival was 79 days (2.6 months; range, 1 to 453 days), and the median overall survival was 275 days (9.0 months; range, 15 to 826 days). The most common drug-related grades 3 to 4 toxicities were as follows: neutropenia, 64%; leukopenia, 18%; fatigue, 5%; peripheral neuropathy, 5%; and febrile neutropenia, 4%. Conclusion Eribulin demonstrated activity with manageable tolerability (including infrequent grade 3 and no grade 4 neuropathy) in heavily pretreated patients with MBC when dosed as a short IV infusion on days 1 and 8 of a 21-day cycle.

Activity of gemcitabine/5-FU combination in refractory esophagogastric (EG) cancer.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 147-147
Author(s):  
Elizabeth Won ◽  
David H. Ilson ◽  
Joanne F. Chou ◽  
Marinela Capanu
Keyword(s):  
Systemic Chemotherapy ◽  
Response Rate ◽  
Performance Status ◽  
Single Agent ◽  
Best Supportive Care ◽  
Flat Dose ◽  
Heavily Pretreated ◽  
Previously Treated ◽  
Grade 3 ◽  
Modest Activity

147 Background: Systemic chemotherapy has been demonstrated to improve survival and palliate symptoms in metastatic EG cancer. 2ndline (or more) chemotherapy with best supportive care also improves progression free and overall survival. Single-agent gemcitabine did not show activity in EG cancers (Ann Oncol 11:1161, 2000). Addition of gemcitabine to 5-fluorouracil (5FU) has shown modest activity (Oncology 69:130, 2005). To determine the efficacy and tolerability of gemcitabine with 5FU, we reviewed our experience in patients (pts) with metastatic or advanced EG cancers treated with this regimen. Methods: Retrospective review of MSKCC database for pts with metastatic EG cancer treated with gemcitabine/5FU (or capecitabine) between 1/1/2000 - 12/31/2012. Gemcitabine given at 600-1000mg/m2 day1, day 8 of q21 day cycle or 600-1000mg/m2 q2 weeks. 5FU given at 600-1000m2/m2 IV/48 hrs, with bolus 5FU/Leucovorin (200-400mg/m2 IV) on day 1. Capecitabine most commonly given as 1500-4000mg flat dose daily, in two divided doses, 7 days on/7 days off. Results: Of 146 pts, median age was 60; KPS 70 (50-90); 84% adenocarcinoma, 6% squamous (SCC). Sites of disease: 45% liver; 22% bone, 21% peritoneum. 112(77%) had ≥ 2 sites of disease. Pts were heavily pretreated: 42(29%) 2 prior lines of treatment (tx) for metastatic disease, 37(25%) 3 lines of tx, and 7(5%) 4+ lines of tx. Prior tx: 5FU/platinum (37%); Taxanes (56%); Irinotecan (44%). With gemcitabine, 49(34%) received 5FU and 97(66%) received capecitabine. In 144 evaluable pts, partial response rate was 7%, and stable disease was seen in 33%. Median PFS 1.84 months (95% CI,1.38-2.04) and for adenocarcinoma 2.0 months (95%CI,1.2-2.2) vs 1.2 months (95%CI: 0.9-1.51) for SCC (p =0.068). In the PR group, median PFS was 5.0 months (range 3.7-16.3 mo). Grade 3 toxicity was seen in 19 (13%); 1 pt had Grade 4 toxicity. 3(2%) discontinued treatment due to toxicity. Conclusions: Combination gemcitabine/5FU or capecitabine in metastatic EG cancer may have some limited activity and is well tolerated in a previously treated population. This regimen may be an appropriate palliative option for patients with an intact performance status who have progressed on other regimens. Research supported by Foundation 14.

Cisplatin in the treatment of recurrent childhood primary brain tumors.

1988 ◽  
Vol 6 (1) ◽  
pp. 62-66 ◽  
Author(s):  
R W Walker ◽  
J C Allen
Keyword(s):  
Brain Tumors ◽  
Germ Cell ◽  
Germ Cell Tumor ◽  
Overall Response Rate ◽  
Response Rate ◽  
Cell Tumor ◽  
Primitive Neuroectodermal Tumors ◽  
Primary Brain Tumors ◽  
Overall Response ◽  
Neuroectodermal Tumors

Thirty-three patients were treated with intravenous (IV) cisplatin (CPDD) of whom 32 were considered evaluable. There were 14 medulloblastomas, five primitive neuroectodermal tumors (PNET), nine gliomas, three ependymomas, and one germ cell tumor. The overall response rate was 13 of 32 (41%). Eleven responses (five complete [CR], five partial [PR], one mixed [MR]) were noted in the patients with medulloblastoma. The response rate within this group was 79%. Toxicity was tolerable, although it precluded further therapy in five patients.

Phase III Study of Intravenous Vinorelbine in Combination With Epirubicin Versus Epirubicin Alone in Patients With Advanced Breast Cancer: A Scandinavian Breast Group Trial (SBG9403)

2004 ◽  
Vol 22 (12) ◽  
pp. 2313-2320 ◽  
Author(s):  
Bent Ejlertsen ◽  
Henning T. Mouridsen ◽  
Sven T. Langkjer ◽  
Jorn Andersen ◽  
Johanna Sjöström ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Response Rate ◽  
Complete Response Rate ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Complete Response ◽  
Phase Iii ◽  
Severe Toxicity ◽  
Free Survival

Purpose To determine whether the addition of intravenous (IV) vinorelbine to epirubicin increased the progression-free survival in first-line treatment of metastatic breast cancer. Patients and Methods A total of 387 patients were randomly assigned to receive IV epirubicin 90 mg/m2 on day 1 and vinorelbine 25 mg/m2 on days 1 and 8, or epirubicin 90 mg/m2 IV on day 1. Both regimens were given every 3 weeks for a maximum of 1 year but discontinued prematurely in the event of progressive disease or severe toxicity. In addition, epirubicin was discontinued at a cumulative dose of 1,000 mg/m2 (950 mg/m2 from June 1999). Prior anthracycline-based adjuvant chemotherapy and prior chemotherapy for metastatic breast cancer was not allowed. Reported results were all based on intent-to-treat analyses. Results Overall response rates to vinorelbine and epirubicin, and epirubicin alone, were 50% and 42%, respectively (P = .15). The complete response rate was significantly superior in the combination arm (17% v 10%; P = .048) as was median duration of progression-free survival (10.1 months v 8.2 months; P = .019). Median survival was similar in the two arms (19.1 months v 18.0 months; P = .50). Leukopenia related complications, stomatitis, and peripheral neuropathy were more common in the combination arm. The incidences of cardiotoxicity and constipation were similar in both arms. Conclusion Addition of vinorelbine to epirubicin conferred a significant advantage in terms of complete response rate and progression-free survival, but not in terms of survival.

Multiagent Chemotherapy and Deferred Radiotherapy in Infants With Malignant Brain Tumors: A Report From the Children’s Cancer Group

2005 ◽  
Vol 23 (30) ◽  
pp. 7621-7631 ◽  
Author(s):  
J. Russell Geyer ◽  
Richard Sposto ◽  
Mark Jennings ◽  
James M. Boyett ◽  
Richard A. Axtell ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Brain Tumors ◽  
Induction Chemotherapy ◽  
Metastatic Disease ◽  
Response Rate ◽  
Residual Tumor ◽  
Study Entry ◽  
Receive Radiation Therapy ◽  
Malignant Brain Tumors ◽  
Significant Difference

Purpose To evaluate response rate, event-free survival (EFS), and toxicity of two chemotherapeutic regimens for treatment of children younger than 36 months with malignant brain tumors and to estimate control intervals without irradiation in children with no residual tumor after initial surgery and induction chemotherapy and with delayed irradiation in patients with residual tumor or metastatic disease at diagnosis. Patients and Methods Patients were randomly assigned to one of two regimens of induction chemotherapy (vincristine, cisplatin, cyclophosphamide, and etoposide v vincristine, carboplatin, ifosfamide, and etoposide). Maintenance chemotherapy began after induction in children without progressive disease. Children with no residual tumors after induction therapy and no metastatic disease at diagnosis were not to receive radiation therapy unless their tumors progressed. Results Two hundred ninety-nine infants were enrolled. Forty-two percent of patients responded to induction chemotherapy. At 5 years from study entry, the EFS rate was 27% ± 3%, and the survival rate was 43% ± 3%. There was no significant difference between the two arms in terms of response rate or EFS. For medulloblastoma, supratentorial primitive neuroectodermal tumor, ependymoma, and rhabdoid tumors, 5-year EFS rates were 32% ± 5%, 17% ± 6%, and 32% ± 6%, and 14% ± 7%, respectively. Fifty-eight percent of patients who were alive 5 years after study entry had not received radiation therapy. Conclusion Intensified induction chemotherapy resulted in a high response rate of malignant brain tumors in infants. Survival was comparable to that of previous studies, and most patients who survived did not receive radiation therapy.

Pentostatin and Cyclophosphamide: An Effective New Regimen in Previously Treated Patients With Chronic Lymphocytic Leukemia

2003 ◽  
Vol 21 (7) ◽  
pp. 1278-1284 ◽  
Author(s):  
Mark A. Weiss ◽  
Peter G. Maslak ◽  
Joseph G. Jurcic ◽  
David A. Scheinberg ◽  
Timothy B. Aliff ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Response Rate ◽  
Median Number ◽  
Lymphocytic Leukemia ◽  
Severe Nausea ◽  
Treatment Regimens ◽  
Purine Analogs ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
Grade 3

Purpose: Purine analogs and alkylators are important agents in the treatment of chronic lymphocytic leukemia (CLL). Previously, combinations of fludarabine and chlorambucil were abandoned because of increased toxicity from overlapping myelosuppression and immunosuppression. Of the purine analogs active in CLL, pentostatin may be least myelosuppressive. We hypothesized that combining pentostatin with cyclophosphamide would have less myelotoxicity than combinations using other purine analogs. Patients and Methods: We studied 23 patients with previously treated CLL. All patients received pentostatin 4 mg/m2. Seventeen patients received cyclophosphamide 600 mg/m2, and six patients received cyclophosphamide 900 mg/m2. Both drugs were administered on day 1 of each cycle, and cycles were repeated every 3 weeks for six treatments. Filgrastim, sulfamethoxazole/trimethoprim, and acyclovir were administered prophylactically. The median number of prior treatment regimens was three (range, one to five) with 13 patients (57%) refractory to prior fludarabine therapy. Results: The cyclophosphamide 900 mg/m2 dose level was associated with moderate to severe nausea, and we chose cyclophosphamide 600 mg/m2 as the dose for further study. There were 17 responses (74%; 95% confidence interval, 63% to 85%), including four complete responses. The response rate was 77% in fludarabine-refractory patients. Myelosuppression was acceptable with grade 3/4 neutropenia and thrombocytopenia, seen in 35% and 30% of patients, respectively. The relative sparing of thrombopoiesis can be seen in that only one patient (5%) with an initial platelet count of more than 20,000 required platelet transfusions while receiving therapy. Conclusion: Pentostatin 4 mg/m2 with cyclophosphamide 600 mg/m2 is safe and effective in previously treated patients with CLL. On the basis of these results, we are currently studying pentostatin, cyclophosphamide, and rituximab (PCR) therapy in patients with CLL.

Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure

Blood ◽  
2008 ◽  
Vol 112 (12) ◽  
pp. 4445-4451 ◽  
Author(s):  
Michael Wang ◽  
Meletios A. Dimopoulos ◽  
Christine Chen ◽  
M. Teresa Cibeira ◽  
Michel Attal ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Response Rate ◽  
Response Rate ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Time To Progression ◽  
Free Survival ◽  
Refractory Multiple Myeloma ◽  
Previously Treated ◽  
Survival Studies

AbstractThis analysis assessed the efficacy and safety of lenalidomide + dexamethasone in patients with relapsed or refractory multiple myeloma (MM) previously treated with thalidomide. Of 704 patients, 39% were thalidomide exposed. Thalidomide-exposed patients had more prior lines of therapy and longer duration of myeloma than thalidomide-naive patients. Lenalidomide + dexamethasone led to higher overall response rate (ORR), longer time to progression (TTP), and progression-free survival (PFS) versus placebo + dexamethasone despite prior thalidomide exposure. Among lenalidomide + dexamethasone-treated patients, ORR was higher in thalidomide-naive versus thalidomide-exposed patients (P = .04), with longer median TTP (P = .04) and PFS (P = .02). Likewise for dexamethasone alone-treated patients (P = .03 for ORR, P = .03 for TTP, P = .06 for PFS). Prior thalidomide did not affect survival in lenalidomide + dexamethasone-treated patients (36.1 vs 33.3 months, P > .05). Thalidomide-naive and thalidomide-exposed patients had similar toxicities. Lenalidomide + dexamethasone resulted in higher rates of venous thromboembolism, myelosuppression, and infections versus placebo + dexamethasone, independent of prior thalidomide exposure. Lenalido-mide + dexamethasone was superior to placebo + dexamethasone, independent of prior thalidomide exposure. Although prior thalidomide may have contributed to inferior TTP and PFS compared with thalidomide-naive patients, these parameters remained superior compared with placebo + dexamethasone; similar benefits compared with placebo + dexamethasone were not evident for thalidomide-exposed patients in terms of overall survival. Studies were registered at http://www.clinicaltrials.gov under NCT00056160 and NCT00424047.

VAD-PECC regimen in the treatment of advanced-stage multiple myeloma.

1994 ◽  
Vol 12 (12) ◽  
pp. 2706-2713 ◽  
Author(s):  
M Delain ◽  
C Linassier ◽  
C Petitdidier ◽  
P Goupille ◽  
F Luthier ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Therapeutic Response ◽  
Response Rate ◽  
Cox Model ◽  
Univariate Analysis ◽  
Karnofsky Score ◽  
Term Survival ◽  
Baseline Serum ◽  
Previously Treated Patients ◽  
Previously Treated

PURPOSE This prospective study was undertaken to evaluate the efficacy of combination chemotherapy with alternating cycles of vincristine, doxorubicin, and dexamethasone (VAD) and prednisone, vindesine, carmustine, and cyclophosphamide (PECC) in poor-risk multiple myeloma (MM). PATIENTS AND METHODS Forty-four patients were previously untreated; 36 had been pretreated with an alkylating agent-containing regimen and had refractory or relapsed MM. All previously untreated patients had a high tumor burden at inclusion (stage III according to the Durie and Salmon classification). Logistic regression and the Cox proportional hazards models were used to assess the association between patient characteristics and response rate and survival, respectively. RESULTS The overall response rate was 68% for previously untreated patients, compared with 54% for previously treated patients (P = .16). The median survival time for all patients was 28 months: 53 months in previously untreated patients, and 18 months in previously treated patients. Univariate analysis showed that the predictive factors that had a significant affect on survival in the newly diagnosed patients were age, therapeutic response to VAD-PECC, low pretreatment Karnofsky score, high baseline serum beta 2-microglobulin (beta 2M) level, bone marrow impairment, and renal insufficiency at the start of treatment. When these parameters were used as continuous variables in multivariate analysis, three were found to correlate with survival: serum beta 2M, followed by therapeutic response and Karnofsky score. In the previously treated group, only Karnofsky score entered the Cox model. CONCLUSION These results indicate that combination VAD-PECC chemotherapy is an effective treatment that results in high response rates and long-term survival in advanced MM.

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