Retrospective review of locally advanced head and neck cancer treated with concomitant chemoradiotherapy at the Miami VA Medical Center

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15541-15541
Author(s):  
C. Robles ◽  
C. Vale ◽  
V. Dinh ◽  
N. Savaraj ◽  
S. Spector ◽  
...  
Keyword(s):  
Head And Neck ◽  
Organ Preservation ◽  
Medical Center ◽  
Locally Advanced ◽  
Stage Iv ◽  
Standard Of Care ◽  
Stage Iii ◽  
Distant Relapse ◽  
History Of ◽  
Transient Elevation

15541 Management of Stage III or IV Head and Neck (H&N) cancer is debatable. Standard of care is Radical Surgery (Sx) followed by Radiotherapy (XRT). However, cosmetic and functional complications are distressing and result in decreased quality of life. Therefore, organ preservation has become important when deciding best management. The VA larynx study, the EORTC 24891 and the 91–11 US intergroup trial have shown efficacy of organ preserving chemoradiotherapy (Cx+Rx) comparable to Sx and XRT. These studies are limited to laryngeal and hypopharyngeal cancers and whether same principles can be applied to other H&N sites is unknown. We conducted a retrospective study of stage III & IV H&N cancer treated at our Institution between 1996–2004 to evaluate survival, organ preservation and toxicities. 45 males between 47 to 83 years (median 59.6) were studied. 87% were white and 13% black. 82% had history of tobacco and alcohol abuse, 4% tobacco only, 11% alcohol only and 2% never smoked or drank. The sites of disease were: nasopharynx 1 (2%), oropharynx 19 (42%), base of tongue 10 (22%), larynx 6 (13%) and pharynx 9 (20%). 15 patients (33%) where stage III and 30 (67%) stage IV. The treatment was combined Cx+Rx. The mean dose of XRT was 6697 Cgy and mean cycles of chemotherapy (Cx) were 2.2. Of those, 42 patients (93%) received cisplatin and 5FU, 2 (4%) carboplatin and 5FU and 1 (2%) carbo only. 10 patients (22%) received additional Cx and 14 (31%) underwent additional Sx (neck dissection). 19 patients (42%) are alive, 19 (42%) are death and 7 (16%) were lost to f/u. Median survival is 30.6 months. 1 patient was refractory and 6 relapsed in less than a year. Among them, 4 were local relapses, 1 a neck recurrence (no prior dissection) and 1 a distant relapse. The most common acute toxicities were: Anemia 87%, neutropenia 64%, hyperglycemia 82%, transient elevation of BUN 60% and creatinine 36%, hypo/hypernatremia 64%, severe mucositis 71%, weight loss 76%, N/V 47% and severe dysphagia 27%. Cx+Rx appears to be a safe, feasible and comparable alternative to Sx regardless of the anatomical origin in locally advanced H&N cancer, with the advantage of organ preservation. Additional XRT boost, Cx or Sx could decrease relapses. Further studies are warranted to validate these hypotheses. No significant financial relationships to disclose.

Phase II randomized trial of radiotherapy (RT), cetuximab (E), and pemetrexed (Pem) with or without bevacizumab (B) in locally advanced squamous cell carcinoma of the head and neck (SCCHN).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6043-6043 ◽  
Author(s):  
Athanassios Argiris ◽  
James Ohr ◽  
Greg J. Kubicek ◽  
Uma Duvvuri ◽  
Dwight Earl Heron ◽  
...  
Keyword(s):  
Phase Ii ◽  
Performance Status ◽  
Locally Advanced ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Median Number ◽  
Stage Iii ◽  
Community Practice ◽  
History Of ◽  
Grade 3

6043 Background: We previously developed a novel regimen by the addition of Pem to RT and E (Ann Oncol 2011;22:2482). The current study evaluated PemE in the phase II setting and assessed the addition of B, an anti-VEGF monoclonal antibody, to PemE based on promising data with Pem/B (JCO 2011;29:1140) and E/B (Ann Oncol 2013;24:200) in recurrent/metastatic SCCHN. Methods: Patients (pts) with previously untreated stage III/IV SCCHN of the oropharynx, larynx or hypopharynx, performance status (PS) 0-1, no history of bleeding, and adequate laboratory parameters were randomized after stratification for PS, stage and site to: RT 2 Gy/day to 70Gy, E 250mg/m2 weekly, after a loading dose of 400 mg/m2 1 week prior starting RT, and Pem 500mg/m2 every 21 days x 3 cycles (arm A, PemE), or the same regimen plus B 15mg/kg every 21 days x 3 cycles during RT followed by B maintenance x 8 cycles (arm B, B-PemE), with antibiotic prophylaxis. The primary endpoint was progression-free survival (PFS) with a target of 64% at 2 years; planned sample size was 80. Results: 79 pts were randomized of whom 77 were eligible and analyzable (arm A/B:36/41); oropharynx 65/larynx 12; HPV+ 38/HPV- 15/HPV unknown 24; stage IV 54/stage III 23. 31 pts were enrolled in community centers. Treatment delivery of E and Pem was similar between arms: E, median number of doses 8 (range, 5-11); Pem 3 (2-3); and B 3 (1-3). 5 deaths occurred: 3 due to progression; 1 from unknown cause; 1 pt died from hemoptysis after bronchoscopy within 4 weeks of the 8th cycle of B leading to elimination of B maintenance after the 6th pt was enrolled. 9 pts (2 HPV+) progressed. With a median follow-up of 18 months, the 2-year PFS was 81% vs 87% and the 2-year overall survival (OS) was 96% vs 86% for arm A vs B. Grade 3/4 acute toxicities for arm A vs B (N=59) : dermatitis 3/1 vs 4/1; mucositis 13/2 vs 13/0; neutropenia 7/4 vs 7/3; rash 6/1 vs 8/1; fatigue 1/0 vs 3/0; weight loss 2/0 vs 5/0. Conclusions: Both regimens are feasible in academic and community practice settings with expected toxicities. Preliminary efficacy results are very promising and better than projected, however, the addition of B does not appear to improve outcomes. Clinical trial information: NCT00703976.

Cisplatin, fluorouracil with leucovorin calcium enhancement, and synchronous accelerated radiotherapy in the management of locally advanced head and neck cancer: a phase II study.

1989 ◽  
Vol 7 (4) ◽  
pp. 471-476 ◽  
Author(s):  
T G Wendt ◽  
R C Hartenstein ◽  
T P Wustrow ◽  
J Lissner
Keyword(s):  
Head And Neck ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Locally Advanced ◽  
Stage Iv ◽  
Distant Metastases ◽  
Stage Iii ◽  
Limiting Factor ◽  
Accelerated Radiotherapy ◽  
Leucovorin Calcium

In a phase II study, patients with locally advanced squamous cell carcinoma of the head and neck were treated with simultaneous chemoradiotherapy. Treatment was divided into three courses. Chemotherapy consisted of cis-diamminedichloroplatinum (II) (cisplatin [cis-DDP]) 60 mg/m2 intravenously (IV), fluorouracil (5-FUra) 350 mg/m2 IV, and folinic acid (leucovorin calcium [FA]) 50 mg/m2 IV on day 2 as bolus, and 5-FUra 350 mg/m2 over 24 hours and FA 100 mg/m2 over 24 hours on days 2 through 5. Radiotherapy consisted of 23.4 Gy over nine days divided into 13 fractions of 1.8 Gy each delivered twice a day from day 3 through day 11. This regimen was repeated on days 22 and 44. Total radiation dose amounted to 70.2 Gy over 51 days. Between August 1984 and October 1986, 62 (modified AJCC stage III, four; IV A, eight; IV B, 50) consecutive patients were entered in the study. Three patients died during treatment due to tumor hemorrhage. Of 59 patients, 48 (81%) achieved a clinically complete response (cCR); 11 (19%) achieved a partial response (cPR). Mean follow-up of the surviving patients was 29+ (24 to 44) months. Actuarial 2-year survival probability is 52%, including three early deaths from tumor bleeding. Tumor and neck nodes control rates at 2 years were 92% for stage III and IV A patients and 65% for stage IV B patients. Patients with cCR had a significantly better 2-year tumor and neck nodes control probability compared with patients who achieved cPR after therapy (P less than .001). Six patients developed distant metastases. Overall toxicity was tolerable, mucositis particularly was not a limiting factor.

Induction Chemotherapy in Locally Advanced Head and Neck Cancer: A New Standard of Care?

2008 ◽  
Vol 22 (6) ◽  
pp. 1155-1163 ◽  
Author(s):  
Jochen H. Lorch ◽  
Marshall R. Posner ◽  
Lori J. Wirth ◽  
Robert I. Haddad
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Induction Chemotherapy ◽  
Neck Cancer ◽  
Locally Advanced ◽  
Standard Of Care ◽  
Advanced Head

scholarly journals 300 Final analysis of a prospective, randomized, double-blind, placebo-controlled phase IIb trial of tumor lysate, particle-loaded, dendritic cell vaccine in stage III/IV melanoma: 36-month analysis

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A327-A327
Author(s):  
Lexy Adams ◽  
Robert Chick ◽  
Guy Clifton ◽  
Timothy Vreeland ◽  
Patrick McCarthy ◽  
...  
Keyword(s):  
Disease Free Survival ◽  
Stage Iv ◽  
Standard Of Care ◽  
Stage Iii ◽  
Tumor Lysate ◽  
Double Blind ◽  
Free Survival ◽  
Resected Stage ◽  
Disease Free ◽  
Stage Iv Melanoma

BackgroundThe tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is created ex vivo by loading autologous dendritic cells (DC) with yeast cell wall particles (YCWP) containing autologous tumor lysate, thus delivering tumor antigens to the DC cytoplasm via phagocytosis. TLPLDC then activates a robust T cell response against the unique antigens for each patient. The primary analysis of the prospective, randomized, multi-center, double-blind, placebo-controlled phase IIb trial in patients with resected stage III/IV melanoma showed TLPLDC improved 24-month disease-free survival (DFS) in the per-treatment (PT) analysis (patients completing the 6-month primary vaccine series). Here, we examine the secondary endpoint of 36-month DFS and overall survival (OS).MethodsPatients with resected stage III/IV melanoma were randomized 2:1 to TLPLDC vaccine or placebo (autologous DC loaded with empty YCWP). Treatments were given at 0, 1, 2, 6, 12 and 18 months. The protocol was amended to include patients receiving concurrent checkpoint inhibitors (CPIs) to follow changes in standard of care. The co-primary endpoints were 24-month DFS by intention-to-treat (IT) analysis and per-treatment (PT) analysis, with secondary endpoints including 36-month DFS and OS by ITT and PT analysis, pre-specified analysis by stage, and safety as measured by CTCAE v4.03.ResultsOverall, 103 patients received TLPLDC and 41 placebo. In PT analysis, 65 patients received TLPLDC and 32 placebo. Total adverse events (AEs), grade 3+ AEs, and serious AEs (SAEs) were similar in placebo vs TLPLDC groups, with one related SAE per treatment arm. By ITT analysis, 36-month OS was 76.2% for TLPLDC vs 70.3% for placebo (HR 0.72, p=0.437) and 36-month DFS was 35.6% vs 27.1% (HR 0.95, p=0.841). By PT analysis, 36-month DFS was improved with TLPLDC (57.5% vs 35.0%; HR 0.50, p=0.025, figure 1). This effect was even more dramatic in resected stage IV patients (36-month DFS: 60.9% vs 0%; HR 0.12, p=0.001, figure 2).ConclusionsThis phase IIb trial again demonstrates the safety of the TLPLDC vaccine, and an improved 36-month DFS in patients with resected stage III/IV melanoma who complete the primary vaccine series, particularly in the stage IV subgroup. Next, a phase III trial will evaluate the efficacy of TLPLDC vaccine as adjuvant treatment for resected stage IV melanoma, with patients randomized to receive standard of care PD-1 inhibitors + TLPLDC versus PD-1 inhibitors + placebo.Abstract 300 Figure 136-month disease free survival for patients receiving TLPLDC vs placebo by PT analysisAbstract 300 Figure 236-month disease free survival for subset of stage IV melanoma patients receiving TLPLDC vs placebo by PT analysisTrial RegistrationThis is a phase IIb clinical trial registered under NCT02301611Ethics ApprovalThis study was approved by Western IRB, protocol 20141932.

Impact of COVID19 pandemic on treatment outcome of locally-advanced head and neck squamous cell carcinoma (LA-HNSCC): IMPACCT study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6061-6061
Author(s):  
Pau Guillen Sentis ◽  
Carmen Castillo Manzano ◽  
Beatriz Quirós ◽  
Francisca Morey Cortes ◽  
Sara Tous ◽  
...  
Keyword(s):  
Negative Impact ◽  
Locally Advanced ◽  
Standard Of Care ◽  
Stage Iii ◽  
Rank Test ◽  
Historical Cohort ◽  
First Semester ◽  
Kaplan Meier ◽  
Chi Squared ◽  
One Year

6061 Background: Treatment (ttm) of cancer patients (pts) was compromised during the first wave of COVID19 pandemic due to collapse of healthcare systems. Standard of care (SOC) for LA-HNSCC pts had to be adapted as operating rooms were temporarily unavailable, and to reduce risk of COVID19 exposure. The IMPACCT study evaluated the outcome of LA-HNSCC pts treated at the Catalan Institute of Oncology during the first semester of 2020 and compared it to a control cohort previously treated in the same institution. Methods: Retrospective single institution analysis of two consecutively-treated cohorts of newly-diagnosed HNSCC pts: from January to June of 2020 (CT20) and same period of 2018 and 2019 (CT18-19). Pt demographics and disease characteristics were obtained from our in-site prospective database. Ttm modifications from SOC as per COVID19-contingency protocol in CT20 for LA-HNSCC were collected. Chi-squared was used to compare variables and ttm response between cohorts. One-year recurrence-free survival (1yRFS) and overall survival (1yOS) of LA-HNSCC pts were estimated by Kaplan-Meier method and compared by Log-rank test. Results: A total of 306 pts were included: CT20=99; CT18-19=207. Baseline characteristics were balanced between cohorts (Table1). In pts treated with conservative ttm (non-surgical approach), persistence disease was higher in CT20 vs CT18-19 (26 vs. 10% p=0.02). Median follow-up of CT20 and CT18-19 was 6.8 months (IQR 5.1-7.9) and 12.3 (6.7-18.4), respectively. A trend towards lower 1yRFS and 1yOS was observed in CT20 vs CT18-19 (72 vs 83% p=0.06; 80 vs 84% p=0.07), respectively. Within CT20, 37 pts (37%) had one or more ttm modifications: switch from surgery to conservative ttm (n=13); altered radiotherapy fractionation (n=14); reduced cisplatin cumulative dose to 200mg/m2 (n=19); no adjuvant ttm (n=1). Pts who received modified ttm had no differences in 1yRFS vs those who did not (80 vs 66% p=0.31), but higher 1yOS was observed (97 vs 67% p<0.01). When stratified by stage, 1yOS difference remained significant in stage III/IVA (100 vs 61% p<0.01) but not in I/II (100 vs 77% p=0.28) or IVB (67 vs 50% p=0.54). Conclusions: COVID19 pandemic had a negative impact on ttm outcomes and survival in LA-HNSCC pts when compared to our historical cohort. Ttm modifications based on COVID19-contingency protocol did not compromise ttm efficacy in terms of RFS and was associated with better OS in Stage III/IVA.[Table: see text]

scholarly journals Special Issue about Head and Neck Cancers: HPV Positive Cancers

2020 ◽  
Vol 21 (9) ◽  
pp. 3388 ◽  
Author(s):  
Panagiota Economopoulou ◽  
Ioannis Kotsantis ◽  
Amanda Psyrri
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Economic Status ◽  
Locally Advanced ◽  
Standard Of Care ◽  
Papilloma Virus ◽  
High Risk Sexual Behavior ◽  
Hpv Status ◽  
Delays In Diagnosis

The oropharynx has become the leading primary site for Human Papilloma Virus (HPV)-associated head and neck cancer. HPV positive oropharyngeal squamous cell carcinoma (HPV+ OSCC) has emerged as an epidemic not easily recognized by many physicians, resulting in delays in diagnosis and management. HPV+ OSCC traditionally refers to younger, healthier patients with high economic status and high-risk sexual behavior and is related to improved prognosis. De-intensification strategies are being evaluated in ongoing clinical trials and if validated, might help spare severe morbidity associated with current cisplatin-based chemoradiotherapy, which is the standard of care for all patients with locally advanced head and neck cancer. On the other hand, whether HPV status represents an important prognostic factor for non-oropharyngeal sites remains to be elucidated.

scholarly journals Induction Chemotherapy in Head and Neck Squamous Cell Carcinoma: A Question of Belief

Cancers ◽  
2018 ◽  
Vol 11 (1) ◽  
pp. 15 ◽  
Author(s):  
Andy Karabajakian ◽  
Max Gau ◽  
Thibault Reverdy ◽  
Eve-Marie Neidhardt ◽  
Jérôme Fayette
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Induction Chemotherapy ◽  
Squamous Cell ◽  
Locally Advanced ◽  
Standard Of Care ◽  
Neck Squamous Cell Carcinoma ◽  
Larynx Preservation ◽  
Distant Failure

Induction chemotherapy (IC) in locally advanced head and neck squamous cell carcinoma (LA HNSCC) has been used for decades. However, its role is yet to be clearly defined outside of larynx preservation. Patients with high risk of distant failure might potentially benefit from sequential treatment. It is now widely accepted that TPF (docetaxel, cisplatin, and fluorouracil) is the standard IC regimen. Essays that have compared this approach with the standard of care, concurrent chemoradiotherapy (CCRT), are mostly inconclusive. Radiotherapy (RT) can be used in the post-IC setting and be sensitized by chemotherapy or cetuximab. Again, no consensus exists but there seems to be trend in favor of potentiation by cisplatin. Less toxic schemes of IC are tested as toxicity is a major issue with TPF. IC might have an interesting role in human papilloma virus (HPV)-related LA HNSCC and lead to CCRT de-escalation.

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