Results of Induction Chemotherapy in Children Older Than 1 Year With a Stage 4 Neuroblastoma Treated With the NB 97 French Society of Pediatric Oncology (SFOP) Protocol

2005 ◽  
Vol 23 (3) ◽  
pp. 532-540 ◽  
Author(s):  
Dominique Valteau-Couanet ◽  
Jean Michon ◽  
Andrée Boneu ◽  
Chantal Rodary ◽  
Yves Perel ◽  
...  

Purpose To test the metastatic response rate in stage 4 neuroblastoma, using dose-intensive induction chemotherapy in a multi-institutional setting. Patients and Methods From 1998 to 1999, 47 consecutive children were treated according to N7 protocol. Children received cyclophosphamide 140 mg/kg, doxorubicin 75 mg/m2, and vincristine 0.066 mg/kg (CAV) in cycles 1, 2, 4, and 6, and cisplatinum 200 mg/m2 and etoposide 600 mg/m2 (P/VP) in cycles 3, 5, and 7. The International Neuroblastoma Staging system was used with an emphasis on skeletal evaluation by 123-iodine-metaiodobenzylguanidine (MIBG) scintigraphy. A phase II study evaluating the metastasis complete response rate after induction chemotherapy was conducted in patients who had positive metastatic sites on MIBG scans at diagnosis. Results Forty-six patients were assessable for toxicity. Hematologic toxicity was the main toxicity observed. Neutropenia was more frequent after CAV than after P/VP (P < .001). A higher rate of thrombocytopenia was observed after P/VP (P = .03). Forty patients with positive MIBG were assessable for metastatic response, and complete regression of metastases was achieved in 17 patients (ie, 43%; 95% CI, 27% to 59%). Of all 47 patients, 21 achieved complete metastatic response. Conclusion The N7 induction chemotherapy protocol was feasible in a multicentric setting. The observed metastasis complete response rate was similar to that obtained in our previous studies and significantly lower than that published in a previous series using the same regimen. In our hands, escalating doses of cyclophosphamide and prolonging conventional chemotherapy with the same drugs failed to improve the metastasis complete response rate.

2005 ◽  
Vol 23 (4) ◽  
pp. 694-704 ◽  
Author(s):  
M.S. Czuczman ◽  
A. Koryzna ◽  
A. Mohr ◽  
C. Stewart ◽  
K. Donohue ◽  
...  

Purpose To evaluate the safety and efficacy of fludarabine plus rituximab in treatment-naïve or relapsed patients with low-grade and/or follicular non-Hodgkin's lymphoma. Patients and Methods This was an open-label, single-arm, single-center phase II study enrolling 40 patients. During the first week of the study, patients received two infusions of rituximab 375 mg/m2 administered 4 days apart. Seventy-two hours after the second infusion of rituximab, patients received the first of six cycles of fludarabine chemotherapy (25 mg/m2/d for 5 days on a 28-day cycle). Single infusions of rituximab were administered 72 hours before the second, fourth, and sixth cycles of fludarabine, and two infusions of rituximab were given 4 weeks after the last cycle of fludarabine. Treatment duration was 26 weeks. Results An overall response rate of 90% (80% complete response rate) was achieved in the intent-to-treat population. Similar response rates were seen in treatment-naïve and previously treated patients. The median duration of response has not been reached at 40+ months. The median follow-up time in this study is 44 months (range, 15 to 66 months). In patients positive for the 14;18 translocation in blood and/or marrow at enrollment, molecular remission was achieved in 88% of cases, with patients remaining negative for up to 4 years to date. Hematologic toxicity was manageable, and except for a 15% incidence of herpes simplex/zoster infections, infectious complications were rare. Nonhematologic toxicities were minimal. Conclusion Rituximab plus fludarabine was well tolerated and associated with an excellent complete response rate, including molecular remissions, in patients with low-grade or follicular lymphoma.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e16521-e16521
Author(s):  
Juan J. Rodriguez-Riao ◽  
George Oblitas ◽  
Virgilio Colon

e16521 Background: Cervix cancer is a public health problem in developing countries, and the locally advanced disease is the most common stage and patiente with complete response after concurrent radiotherapy and cisplatin is low. In this study we use induction chemotherapy in orden to reduce the tumor before radiotherapy administration. Methods: 47 patients with pathological confirmed cervix cancer stage Ib2 to IVa received induction chemotherapy for three cycles with cisplatin, paclitaxel and capecitabine prior to treatment with concurrent chemotherapy-radiotherapy. The primary end points were clinical response rate, pathological response and imaging after induction and secondary end point was safety (NCI toxicity version 3.0). Results: A total of 47 patients found that the average age was 45 years, stage IIB was the most common, squamous histology representing 89.4% of the patients. The clinical response rate was 100%, without disease progression during the period of following. Pathological complete response was 48.9%. The most common hematologic toxicity was anemia (55%) and grade 3 neutropenia (14.8%) but both were manageable, all patients had hand-foot syndrome and alopecia. Neuropathy grade 3 was 12.7%. Conclusions: Induction chemotherapy whith cisplatin, paclitaxel and capecitabine for three cycles prior to standard treatment offers an effective and safety alternative in patients with locally advanced cervical carcinoma.


2004 ◽  
Vol 22 (15) ◽  
pp. 3061-3069 ◽  
Author(s):  
A. Psyrri ◽  
M. Kwong ◽  
S. DiStasio ◽  
L. Lekakis ◽  
M. Kassar ◽  
...  

Purpose The poor functional outcome in patients with advanced head and neck squamous cell carcinoma (HNSCC) with surgery and radiation has led to alternative approaches to advanced disease. We conducted a phase II study of induction chemotherapy followed by concurrent chemoradiotherapy for organ preservation in patients with advanced resectable and unresectable (nasopharyngeal) tumors. Patients and Methods Forty-two patients with stage III to IV resectable HNSCC and nasopharyngeal tumors received induction chemotherapy with two courses of cisplatin (20 mg/m2/d continuous infusion [CI]), fluorouracil (800 mg/m2/d CI), and leucovorin (500 mg/m2/d CI; PFL) for 4 days followed by concurrent therapy with cisplatin (100 mg/m2/d on days 1 and 22) and approximately 70 Gy of external-beam radiotherapy. Results Response to induction chemotherapy included partial response rate of 52% and complete response rate of 24%. The most common grade 3 or 4 toxicity was neutropenia (59%). After cisplatin chemoradiotherapy the complete response rate was 67%. Toxicities of cisplatin chemoradiotherapy consisted of grade 3 or 4 mucositis (79%) and neutropenia (51%). At a median follow-up of 71.5 months, 43% of the patients are still alive and disease-free. The 5-year progression-free survival (PFS) rate was 60%, and the 2- and 5-year overall survival (OS) rates were 67% and 52%, respectively. Three patients died of second primaries. Late complications of treatment included xerostomia and hoarseness. One patient had persistent dysphagia and required laser epiglotectomy 108 months after treatment. Conclusion Induction chemotherapy with PFL followed by concurrent cisplatin chemoradiotherapy is well tolerated and results in a good likelihood of organ preservation and excellent PFS and OS.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6015-6015 ◽  
Author(s):  
H. J. Wanebo ◽  
M. Ghebremichael ◽  
B. Burtness ◽  
S. Spencer ◽  
J. Ridge ◽  
...  

6015 Introduction: Neoadjuvant C225 with induction chemotherapy and chemo-radiation was studied in stage III/IV head and neck squamous cancer with primary and secondary objectives of 1year event- free survival, pathologic complete response rate at the primary site (PS) (determined by mandatory biopsy week 8) and toxicity. Protocol Design: Operable patients (pts) staged by triple endoscopy, CT/MRI, had gastrostomy, signed IRB approved consent and received induction chemotherapy with weekly C225 250 mg/m2, P 90 mg/m2, C (AUC=2). Restaging PS biopsy was done at week 8, if there was a clinical response. Pts with positive biopsy (or persistent tumor) at PS had restaging biopsy at week 14 after chemo radiation (C225 250 mg/m2, P 30 mg/m2, C(AUC=1) and 50 Gy). If PS Bx was negative patients had completion RT (68–72 Gy, plus continued C225, P,C). If PS Bx was positive at 14 weeks salvage surgery was required. Results: 74 patients were enrolled (67 are evaluable). T and N stage were T1/2 (11%/27%), T ¾ (47%/14%); N O/N1 (11%/23 %), N 2/3 (50%/16%). Site: tonsil 30%, oral cavity/tongue 24%, Post pharynx (BOT) 42%, Larynx 34%; performance status 0/1 (61% / 39%). PS re biopsy was done at week 8 in 40 patients; no residual tumor was detected in 26 (65%). Restaging biopsy after induction and chemo radiation was done at week 14 in 28 pts (14 with persistent tumor and 14 with previous positive biopsy) and was negative in all 28 patients. All 54 patients with negative PS biopsy had completion RT. Data on disease status are incomplete. Post treatment toxicity (Gr 3/4) included acneiform rash (12%), leukopenia/neutropenia 32%/24%, dysphagia (29%), and stomatitis (82%). One grade 5 AE occurred (death from encephalopathy). Conclusion: Neoadjuvant induction C225, plus chemotherapy followed by C225 plus chemo-radiation elicited a complete pathologic response at the primary site, by restaging biopsy (65%) with induction alone, and 100% among sampled patients after chemo RT 50Gy. These preliminary results suggest a high pathologic complete response rate to induction chemotherapy plus cetuximab followed by chemo radiation plus cetuximab. Progression and survival data are not yet mature. No significant financial relationships to disclose.


1999 ◽  
Vol 17 (12) ◽  
pp. 3828-3834 ◽  
Author(s):  
Joseph A. Sparano ◽  
Ping Hu ◽  
Radha M. Rao ◽  
Carla I. Falkson ◽  
Antonio C. Wolff ◽  
...  

PURPOSE: Several groups have reported that the combination of doxorubicin plus paclitaxel given as a 3-hour intravenous (IV) infusion for up to eight cycles produces a high response rate (> 80%) and complete response rate (> 20%) in metastatic breast cancer, but is also complicated by a 20% incidence of congestive heart failure (CHF). The purpose of this phase II trial was to evaluate the antineoplastic activity of the regimen in a multi-institutional setting and to reduce the incidence of cardiotoxicity by limiting treatment to a maximum of six cycles. PATIENTS AND METHODS: Fifty-two patients with advanced breast cancer received doxorubicin (60 mg/m2 by IV injection) followed 15 minutes later by paclitaxel (200 mg/m2 by IV infusion over 3 hours) every 3 weeks for four to six cycles. RESULTS: Objective responses occurred in 25 of 48 assessable patients (52%; 95% confidence interval [CI], 38% to 66%), including four complete responses (8%; 95% CI, 0% to 16%). The median cumulative doxorubicin dose given was 240 mg/m2 (range, 132 to 360 mg/m2). Eleven patients (21%) were documented as having a decrease in the LVEF below normal, including three patients (6%; 95% CI, 0% to 12%) who developed CHF. CONCLUSION: The doxorubicin/paclitaxel regimen that we used is unlikely to produce an objective response rate of more than 70% and a complete response rate of more than 20% in patients with metastatic breast cancer, and proved to be excessively cardiotoxic for use in the adjuvant setting.


2004 ◽  
Vol 22 (12) ◽  
pp. 2313-2320 ◽  
Author(s):  
Bent Ejlertsen ◽  
Henning T. Mouridsen ◽  
Sven T. Langkjer ◽  
Jorn Andersen ◽  
Johanna Sjöström ◽  
...  

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.


Oncotarget ◽  
2018 ◽  
Vol 9 (41) ◽  
pp. 26406-26416 ◽  
Author(s):  
Angela Santonja ◽  
Alfonso Sánchez-Muñoz ◽  
Ana Lluch ◽  
Maria Rosario Chica-Parrado ◽  
Joan Albanell ◽  
...  

2020 ◽  
Vol 4 (17) ◽  
pp. 4091-4101
Author(s):  
Arne Kolstad ◽  
Tim Illidge ◽  
Nils Bolstad ◽  
Signe Spetalen ◽  
Ulf Madsbu ◽  
...  

Abstract For patients with indolent non-Hodgkin lymphoma who fail initial anti-CD20–based immunochemotherapy or develop relapsed or refractory disease, there remains a significant unmet clinical need for new therapeutic approaches to improve outcomes and quality of life. 177Lu-lilotomab satetraxetan is a next-generation single-dose CD37-directed radioimmunotherapy (RIT) which was investigated in a phase 1/2a study in 74 patients with relapsed/refractory indolent non-Hodgkin B-cell lymphoma, including 57 patients with follicular lymphoma (FL). To improve targeting of 177Lu-lilotomab satetraxetan to tumor tissue and decrease hematologic toxicity, its administration was preceded by the anti-CD20 monoclonal antibody rituximab and the “cold” anti-CD37 antibody lilotomab. The most common adverse events (AEs) were reversible grade 3/4 neutropenia (31.6%) and thrombocytopenia (26.3%) with neutrophil and platelet count nadirs 5 to 7 weeks after RIT. The most frequent nonhematologic AE was grade 1/2 nausea (15.8%). With a single administration, the overall response rate was 61% (65% in patients with FL), including 30% complete responses. For FL with ≥2 prior therapies (n = 37), the overall response rate was 70%, including 32% complete responses. For patients with rituximab-refractory FL ≥2 prior therapies (n = 21), the overall response rate was 67%, and the complete response rate was 24%. The overall median duration of response was 13.6 months (32.0 months for patients with a complete response). 177Lu-lilotomab satetraxetan may provide a valuable alternative treatment approach in relapsed/refractory non-Hodgkin lymphoma, particularly in patients with comorbidities unsuitable for more intensive approaches. This trial was registered at www.clinicaltrials.gov as #NCT01796171.


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