Cisplatin, Fluorouracil, and Leucovorin Induction Chemotherapy Followed by Concurrent Cisplatin Chemoradiotherapy for Organ Preservation and Cure in Patients With Advanced Head and Neck Cancer: Long-Term Follow-Up

2004 ◽  
Vol 22 (15) ◽  
pp. 3061-3069 ◽  
Author(s):  
A. Psyrri ◽  
M. Kwong ◽  
S. DiStasio ◽  
L. Lekakis ◽  
M. Kassar ◽  
...  
Keyword(s):  
Head And Neck ◽  
Induction Chemotherapy ◽  
Organ Preservation ◽  
Response Rate ◽  
Complete Response Rate ◽  
Complete Response ◽  
Advanced Head ◽  
Nasopharyngeal Tumors ◽  
Grade 3

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.

The VcR-CVAD Regimen Produces a High Complete Response Rate in Untreated Mantle Cell Lymphoma (MCL): First Analysis of E1405 – A Phase II Study of VcR-CVAD with Maintenance Rituximab for MCL.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1661-1661 ◽  
Author(s):  
Brad S Kahl ◽  
Hailun Li ◽  
Mitchell R Smith ◽  
Randy D. Gascoyne ◽  
Elisabeth Paietta ◽  
...  
Keyword(s):  
Phase Ii ◽  
Research Funding ◽  
Response Rate ◽  
Complete Response Rate ◽  
Phase Ii Study ◽  
Cell Lymphoma ◽  
Complete Response ◽  
Mantle Cell ◽  
Grade 3

Abstract Abstract 1661 Poster Board I-687 Introduction One approach to improving outcomes in Mantle Cell Lymphoma (MCL) is to incorporate newer targeted agents into standard chemotherapy regimens. As the proteasome inhibitor bortezomib (Velcade‘) achieved a 33% response rate in relapsed MCL, we hypothesized that the incorporation of Velcade (Vc) into a modified R-hyperCVAD chemotherapy backbone would result in a high complete response rate (CR). The new regimen, VcR-CVAD, was tested for safety and efficacy in a phase II study within the Wisconsin Oncology Network (UW) and demonstrated a CR rate of 77% (Kahl, ASH 2008). To determine the safety and efficacy of this regimen in a cooperative group setting, we initiated E1405: a phase II study of VcR-CVAD with maintenance rituximab (MR) for untreated MCL. Methods Eligible patients had histologically confirmed, previously untreated MCL, PS 0-2, and adequate end organ function. The treatment plan included: Velcade 1.3 mg/m2 days 1 and 4, rituximab 375 mg/m2 IV day 1, cyclophosphamide 300 mg/m2 IV over 3 hrs q 12 hrs X 6 doses days 1-3, doxorubicin 50 mg/m2 continuous infusion over 48 hrs days 1-2, vincristine 1 mg IV day 3, dexamethasone 40 mg po days 1-4. Cycles were repeated every 21 days for 6 cycles and all patients received G-CSF support. Patients achieving SD, PR, or CR received MR administered as 4 weekly treatments every 6 months for 2 years (protocol therapy). Patients had an option to receive high dose chemotherapy and autologous stem cell transplantation (off protocol) rather than MR. The primary endpoint of the trial was the CR rate, incorporating PET imaging, to VcR-CVAD induction therapy. Results Seventy-six eligible patients were enrolled between 5/07 and 10/08. Baseline characteristics include median age 62 (40-76), 59M:17F, 91% stage III/IV, and 39% with elevated LDH. Sixty-four patients (84%) completed VcR-CVAD induction therapy. Reasons for treatment discontinuation included PD (1), toxicity (4), patient preference (2), and other/unknown (5). Response information is available on 74 patients while data is outstanding on 2 patients. The ORR was 96% (73/76; 95% CI, 89%-99%), CR rate 75% (57/76; 95% CI, 64%-84%) and the PR rate 21% (16/76; 95% CI, 13%-32%). Six of the PR patients were coded as such because of protocol violations in which a post-treatment bone marrow biopsy or PET scan was not obtained. The CR rate in the 68 completely restaged patients was 84%. Forty-four patients proceeded to planned MR while 21 patients went off protocol to SCT consolidation. Median follow up is currently too short (9 months) to assess PFS and OS. The major toxicity of the treatment regimen was expected myelosuppression. Grade 3-4 non hematologic toxicities were rare. No patients developed grade 3-4 neuropathy. There were no treatment related deaths. Conclusion The VcR-CVAD induction produced high overall response (96%) and CR rate (75%) in a representative MCL patient population treated on a cooperative group protocol. The CR rate was high and comparable to the UW pilot study (77%). No episodes of severe painful peripheral neuropathy were reported using the reduced vincristine dosage and the overall toxicity profile was very acceptable. Longer follow up is needed to determine if the high CR rate will translate into improved PFS and OS. Disclosures Kahl: Genentech: Consultancy, Research Funding; Millennium: Consultancy, Research Funding. Off Label Use: Bortezomib as front line treatment in MCL. Smith:Genentech: Research Funding; Millennium: Research Funding. Advani:Seattle Genetics, Inc.: Research Funding. Horning:Genentech: Honoraria, Research Funding.

Bortezomib-Melphalan-Prednisone-Thalidomide Followed by Maintenance With Bortezomib-Thalidomide Compared With Bortezomib-Melphalan-Prednisone for Initial Treatment of Multiple Myeloma: Updated Follow-Up and Improved Survival

2014 ◽  
Vol 32 (7) ◽  
pp. 634-640 ◽  
Author(s):  
Antonio Palumbo ◽  
Sara Bringhen ◽  
Alessandra Larocca ◽  
Davide Rossi ◽  
Francesco Di Raimondo ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Response Rate ◽  
Complete Response Rate ◽  
Progression Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Grade 3 ◽  
To Receive

Purpose Bortezomib-melphalan-prednisone (VMP) has improved overall survival in multiple myeloma. This randomized trial compared VMP plus thalidomide (VMPT) induction followed by bortezomib-thalidomide maintenance (VMPT-VT) with VMP in patients with newly diagnosed multiple myeloma. Patients and Methods We randomly assigned 511 patients who were not eligible for transplantation to receive VMPT-VT (nine 5-week cycles of VMPT followed by 2 years of VT maintenance) or VMP (nine 5-week cycles without maintenance). Results In the initial analysis with a median follow-up of 23 months, VMPT-VT improved complete response rate from 24% to 38% and 3-year progression-free-survival (PFS) from 41% to 56% compared with VMP. In this analysis, median follow-up was 54 months. The median PFS was significantly longer with VMPT-VT (35.3 months) than with VMP (24.8 months; hazard ratio [HR], 0.58; P < .001). The time to next therapy was 46.6 months in the VMPT-VT group and 27.8 months in the VMP group (HR, 0.52; P < .001). The 5-year overall survival (OS) was greater with VMPT-VT (61%) than with VMP (51%; HR, 0.70; P = .01). Survival from relapse was identical in both groups (HR, 0.92; P = .63). In the VMPT-VT group, the most frequent grade 3 to 4 adverse events included neutropenia (38%), thrombocytopenia (22%), peripheral neuropathy (11%), and cardiologic events (11%). All of these, except for thrombocytopenia, were significantly more frequent in the VMPT-VT patients. Conclusion Bortezomib and thalidomide significantly improved OS in multiple myeloma patients not eligible for transplantation.

scholarly journals Effect of Concurrent Chemoradiation for Advanced Head and Neck Malignancy in a Tertiary Care Centre, Kerala

2021 ◽  
Vol 10 (28) ◽  
pp. 2094-2098
Author(s):  
Ravisankar Thommanparambil Raveendran ◽  
Shehna Abdul Khader ◽  
Ajith Kumar Vilasini Raghavan ◽  
Jayaraman Madambath Balan ◽  
Krishnannair Lalithamma Jayakumar
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Response Rate ◽  
Complete Response Rate ◽  
Locally Advanced ◽  
Complete Response ◽  
Concurrent Chemotherapy ◽  
Advanced Head ◽  
One Year

BACKGROUND Concurrent chemotherapy is a well-established treatment modality for locally advanced head and neck cancer. The concept of concurrent chemotherapy and radiation was introduced in an attempt to improve the local control and possibly influence the survival because of the high rate of local and distant failures observed with the combination of surgery and postoperative radiation. The relevance of this study was to assess the efficacy of our treatment and patience compliance and also study the effect in patients treated with cisplatin based concurrent chemo radiotherapy in advanced head and neck cancer. METHODS The prospective study was conducted in the Department of Radiotherapy, Government Medical college, Thrissur, Kerala comprising the newly diagnosed patients with locally advanced head & neck cancers over one year. Conventional radiotherapy with a dose of 66 Gy in 33 fractions over 6.5 weeks was given concurrently with Inj cisplatin 100 mg / 2 IV every 3 weeks and periodically followed up for one year. RESULTS This study revealed that complete response rate was higher in 61 – 70 year age group compared to lower age groups. Complete response cases were slightly higher in T1 disease compared to higher stages. Regarding nodal status, complete response and DFS were more in N0 tumours and worst in N3 tumours. It was found that complete response rates were slightly higher in stage III than stage IV. Comparing the grade of the tumour, complete response cases were slightly higher in WD and MD compared to PD. Complete response rate and disease free survival (DFS) were slightly higher in cases who had more than two chemotherapy cycles compared to one cycle. CONCLUSIONS Concurrent chemo radiation was not well tolerated in our study group. Only 23.5 % patients were able to complete the planned treatment. The positive side was that complete response was found in about 79.4 % of study patients & DFS at one year was 80 %. KEY WORDS Concurrent Chemo Radiation, Head and Neck Cancer, Cisplatin

Phase II trial of paclitaxel, ifosfamide, and cisplatin in patients with recurrent head and neck squamous cell carcinoma.

1998 ◽  
Vol 16 (4) ◽  
pp. 1325-1330 ◽  
Author(s):  
D M Shin ◽  
B S Glisson ◽  
F R Khuri ◽  
L Ginsberg ◽  
V Papadimitrakopoulou ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Response Rate ◽  
Complete Response Rate ◽  
Complete Response ◽  
Regional Recurrence ◽  
Grade 3 ◽  
Local Regional Recurrence

PURPOSE To assess the activity and toxicity profile of combined taxol (paclitaxel), ifosfamide, and platinum (cisplatin) (TIP) in patients with recurrent or metastatic squamous cell carcinoma (SCC) of the head and neck. PATIENTS AND METHODS Recurrent or metastatic head and neck SCC patients received paclitaxel 175 mg/m2 in a 3-hour infusion on day 1; ifosfamide 1,000 mg/m2 in a 2-hour infusion on days 1 through 3; mesna 600 mg/m2 on days 1 through 3; and cisplatin 60 mg/m2 on day 1, repeated every 3 to 4 weeks. All were premedicated with dexamethasone, diphenhydramine, and cimetidine. Prophylactic hematopoietic growth factors were not permitted. RESULTS Fifty-two patients were assessable for response and toxicity; 53 for survival (local-regional recurrence alone in 57% and distant metastasis with or without local-regional recurrence in 43%). Overall response rate was 58% (30 of 52) of patients; complete response rate was 17% (nine of 52) of patients, with six complete responses that continued for a median 15.7+ months. Median follow-up of all patients was 17.7 months. Median survival was 8.8 months (95% confidence interval [CI] 8.1 to 17.5 months). Toxicity was relatively well tolerated and caused no deaths. The most frequent moderate-to-severe toxicity (90% of patients) was transient grades 3 to 4 neutropenia; neutropenic fever occurred in 27%. Grade 3 peripheral neuropathy occurred in three patients, none had grade 4. Grade 3 mucositis occurred in only one patient, none had grade 4. CONCLUSION TIP had major activity in this setting, with a 58% objective response rate, 17% complete response rate, durable complete responses (six of nine persisting), and relatively well-tolerated toxicity, with no toxic deaths. The activity of TIP, a novel taxol-cisplatin-based regimen, in recurrent or metastatic head and neck SCC should be confirmed in a phase III trial.

Rituximab Combined to ACVBP (R-ACVBP) Supported by Pegfilgrastim as a New Inductive Treatment Followed by High-Dose Consolidative Autotransplantation (HDC) for Poor Risk Diffuse Large B-Cell Lymphoma (DLBCL) in First-Line. Results of LNH 03–39B. A GELA Study.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3437-3437 ◽  
Author(s):  
Karim Belhadj ◽  
Jean-Philippe Jais ◽  
Pierre Feugier ◽  
Christian Gisselbrecht ◽  
Christian Recher ◽  
...  
Keyword(s):  
Single Dose ◽  
Response Rate ◽  
Complete Response Rate ◽  
B Cell Lymphoma ◽  
Complete Response ◽  
Free Survival ◽  
Cd34 Cells ◽  
Induction Regimen ◽  
Grade 3

Abstract ACVBP dose-intense induction regimen followed by HDC provides a better event-free survival and overall survival (OS) as compared to a conventional consolidative treatment in responding patients (pts) with aggressive lymphoma presenting with 2 or 3 factors of the age-adjusted International Prognostic Index (aa-IPI). However, complete response rate (CRR = CR+CRu) after ACVBP is not superior to 65%. Besides, it is established that Rituximab (R) combined with CHOP improves CRR and OS. Several controlled studies have demonstrated that a single dose of pegfilgrastim provides similar neutrophil recovery than filgrastim after chemotherapy in cancer patients. The main objective of this study was to evaluate the efficacy of a single dose of pegfilgrastim (6 mg) at d3 of the 4 cycles of R-ACVBP inductive regimen (rituximab 375 mg/m2 d1,doxorubicin 75 mg/m2 d1, cyclophosphamide 1,200 mg/m2 d1, vindesine 2 mg/m2, bleomycin 10 mg d1 and d5 and prednisone 60 mg/m2 d1-d5) delivered every 15 days in order to maintain an optimal combined dose intensity (CDI). CDI was defined as the minimum received dose intensities of doxorubicin and cyclophosphamide by each patient. Secondary objectives were to investigate if R combined to ACVBP translates into an improvement of CRR and progression free survival (PFS). The number of leukaphereses and CD34+ cells collected in responding pts were also analyzed. Responding pts received HDC with BEAM followed by stem cell rescue. From 01/2004 to 12/2005, 60 pts were enrolled: median age was 50 y (range: 21–60), 80% with aaIPI 2 and 20% with aa-IPI 3. The mean CDI was 89 (95% CI: 86–93), greater than theoretical cut-off of 85% (p=0.0017). After induction, 63% of pts achieved CR/CRu, 25% were in PR; 2 pts died during the induction phase. At least one episode of grade 3–4 neutropenia was observed in 98% of pts, 67% experienced grade 3–4 anemia, 38% thrombocytopenia and 73% febrile neutropenia. More than 2.106 CD34+ cells/kg were collected in 80% of the pts after the 3rd and/or 4th R-ACVBP while a collection failure was observed in 11 pts (20%), 7 of them being further collected with filgrastim. The median number of leukaphereses was 2. Among the 56 responding pts, 48 received HDC. With a median follow-up of 2 years, 2-year PFS was 71% (95% CI:61–84), and OS was 91% (95% CI:74–97). We conclude that CDI is satisfactory with pegfilgrastim support. R-ACVBP dose-intense induction regimen is feasible and safe on such high-risk pts but does not increase the complete response rate. However, PFS and OS seem encouraging; a longer follow-up is needed to see whether the addition of rituximab definitely contributes to decrease the relapse rate.

Phase II evaluation of cetuximab (C225) combined with induction paclitaxel and carboplatin followed by C225, paclitaxel, carboplatin, and radiation for stage III/IV operable squamous cancer of the head and neck (ECOG, E2303)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6015-6015 ◽  
Author(s):  
H. J. Wanebo ◽  
M. Ghebremichael ◽  
B. Burtness ◽  
S. Spencer ◽  
J. Ridge ◽  
...  
Keyword(s):  
Head And Neck ◽  
Induction Chemotherapy ◽  
Response Rate ◽  
Complete Response Rate ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Primary Site ◽  
Positive Biopsy ◽  
Squamous Cancer ◽  
Pathologic Complete Response Rate

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.

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