ADXS11-001 Lm-LLO Immunotherapy, Mitomycin, 5-fluorouracil (5-FU) and Intensity-modulated radiation therapy (IMRT) for Anal Cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15072-e15072 ◽  
Author(s):  
Howard Safran ◽  
Kara Lynne Leonard ◽  
Thomas A. DiPetrillo ◽  
Adam Klipfel ◽  
Steven Schechter ◽  
...  
Keyword(s):  
Anal Cancer ◽  
Protein Targeting ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Intensity Modulated Radiation Therapy ◽  
Progression Free Survival ◽  
Complete Response ◽  
Additional Patient ◽  
Hpv Dna ◽  
Cell Immunity

e15072 Background: Human papillomavirus (HPV) DNA is present in the majority of anal cancer. ADXS11-001 Lm-LLO immunotherapy is a live attenuated Listeria monocytogenes ( Lm) bioengineered to secrete a HPV-16-E7 fusion protein targeting HPV transformed cells. The Lmvector is phagocytosed by antigen presenting cells where it cross presents, stimulating MHC class 1 and 2 pathways resulting in specific T-cell immunity. The objective of this study was to determine the safety of ADXS11-001 with mitomycin, 5-FU and IMRT (chemoradiation therapy, CRT) and obtain preliminary data on progression free survival (PFS) in locally advanced anal cancer. Methods: Eligibility included patients (pts) with anal squamous cell cancer and stages T1N2-N3; T2( < 4 cm)N1-N3; T2(≥4cm)N0-N3, T3N0-3, T4N0-3; without evidence of metastases. Pts received standard 54 Gy IMRT with 2 cycles of mitomycin and 5-FU. ADXS11-001, 1x109colony forming units IV, was given x 1 dose before CRT then x 3 additional monthly doses after CRT. Results: The study enrolled the first pt in April 2013. Ten patients were treated (median age 62.5, range 37-71) including 5 with pelvic adenopathy. Two patients had grade 3 toxicities related to the vaccine including chills/rigors (n = 2), back pain (n = 1), hyponatremia (n = 1). All toxicities were within 24 hours of the vaccine and resolved successfully with standard care. There was no exacerbation of CRT toxicities or myelosuppression. One patient had a grade 5 cardiopulmonary event shortly after beginning 5-FU treatment which was judged to be unlikely related to ADXS11-001and possibly related to CRT. Eight patients treated on the study had a complete response at six-month sigmoidoscopy. One additional patient who did not undergo six-month sigmoidoscopy had complete response on sigmoidoscopy performed at approximately one year. Eight of 9 patients (89%) are disease-free at a median follow-up of 34 months. Conclusions: ADXS11-001 can be safely administered with CRT for anal cancer. Promising PFS was observed in patients with locally advanced disease. Clinical trial information: NCT01671488.

Cisplatin (CDDP) and radiation versus cetuximab (Cx) and radiation in locally advanced head and neck squamous cell cancer (SCHNC): A retrospective review.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16009-e16009 ◽  
Author(s):  
Prakash Peddi ◽  
Runhua Shi ◽  
Lori Panu ◽  
Fred Ampil ◽  
Cherie-Ann Nathan ◽  
...  
Keyword(s):  
Performance Status ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Complete Response ◽  
Rank Test ◽  
Cancer Center ◽  
Ecog Performance Status ◽  
Chi Square ◽  
Group A

e16009 Background: SCHNC is a common malignancy and approximately 60% of patients present with locally advanced disease. There is paucity of data directly comparing Cx and CDDP with concurrent radiation in locally advanced SCHNC. We retrospectively reviewed charts of patients treated with CDDP and/or Cx along with radiation in locally advanced SCHNC comparing efficacy and outcomes in an academic cancer center. Methods: Ninety-five patients with locally advanced SCHNC were treated with concurrent CDDP (100 mg/m2 day 1, 22, 43) or Cx (400mg/m2 on day -7 and 250mg/m2 weekly) at our institution between January 2006 and June 2011. Forty-four patients were treated with CDDP (group A), 24 with Cx (group B) and 27 were initially started on CDDP but were switched to Cx secondary to toxicity (group C). All patients received concurrent radiation treatments (66-70 Gy, 2.0 Gy/fraction). The selection of CDDP versus Cx was largely based on ECOG performance status (PS) and baseline renal function of the patients. Chi-square test, analysis of variance, and log-rank test was used for analysis. The three groups had similar baseline characteristics except for mean age of 61, 56 and 55 years in group A, B and C respectively; T4 tumors consisted of 44%, 75% and 41% in groups A, B and C respectively. Groups A, B and C had a combined ECOG 0 and I (PS) of 93%, 75% and 92%. Patients with ECOG III PS were excluded. Results: Oropharynx was the most common treated site (38%) followed by Larynx (35%). Complete response (CR) was seen in 77%, 17% and 67% in groups A, B and C respectively (P<0.001). Median progression free survival (PFS) was 16.6, 4.3 and 22.8 in groups A, B and C respectively (P<0.001) and median overall survival (OS) was >35, 11.6 and >32 months in groups A, B and C respectively (P<0.0001). Conclusions: Concurrent CDDP with radiation leads to better response rate PFS and OS as opposed to Cx though many patients treated with CDDP could not complete treatment due to toxicity. Randomized trial comparing the two should be considered.

scholarly journals Proton Therapy for Locally Advanced Oropharyngeal Cancer: Initial Clinical Experience at the University of Washington

2019 ◽  
Vol 6 (3) ◽  
pp. 1-12
Author(s):  
Saif Aljabab ◽  
Andrew Liu ◽  
Tony Wong ◽  
Jay J. Liao ◽  
George E. Laramore ◽  
...  
Keyword(s):  
Clinical Experience ◽  
Proton Therapy ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Late Toxicity ◽  
Complete Response ◽  
Tube Placement ◽  
Treatment Interruptions ◽  
Early Results

Abstract Purpose: Proton therapy can potentially improve the therapeutic ratio over conventional radiation therapy for oropharyngeal squamous cell cancer (OPSCC) by decreasing acute and late toxicity. We report our early clinical experience with intensity-modulated proton therapy (IMPT). Materials and Methods: We retrospectively reviewed patients with OPSCC treated with IMPT at our center. Endpoints include local regional control (LRC), progression-free survival (PFS), overall survival (OS), tumor response, and toxicity outcomes. Toxicity was graded as per the Common Terminology Criteria for Adverse Events v4.03. Descriptive statistics and Kaplan-Meier method were used. Results: We treated 46 patients from March 2015 to August 2017. Median age was 58 years, 93.5% were male, 67% were nonsmokers, 98% had stage III-IVB disease per the 7th edition of the AJCC [American Joint Committee on Cancer] Cancer Staging Manual, and 89% were p16 positive. Twenty-eight patients received definitive IMPT to total dose of 70 to 74.4 Gy(RBE), and 18 patients received postoperative IMPT to 60 to 66 Gy(RBE) following transoral robotic surgery (TORS). Sixty-four percent of patients received concurrent systemic therapy. There were no treatment interruptions or observed acute grade 4 or 5 toxicities. Eighteen patients had percutaneous endoscopic gastrostomy (PEG) tube placement; the majority (14) were placed prophylactically. The most common grade 3 acute toxicities were dermatitis (76%) and mucositis (72%). The most common late toxicity was grade 2 xerostomia (30%). At a median follow-up time of 19.2 months (interquartile range [IQR], 11.2-28.4), primary complete response was 100% and nodal complete response was 92%. One patient required a salvage neck dissection owing to an incomplete response at 4 months. There were no recorded local regional or marginal recurrences, PFS was 93.5%, and OS was 95.7%. Conclusion: Our early results for IMPT in OPSCC are promising with no local regional or marginal recurrences and a favorable toxicity profile. Our data add to a body of evidence that supports the clinical use of IMPT. Randomized comparative trials are encouraged.

37. ADXS11-001, mitomycin, 5-FU and radiation for anal cancera A phase I/II study

Sexual Health ◽  
2013 ◽  
Vol 10 (6) ◽  
pp. 588
Author(s):  
Howard Safran ◽  
Kimberly Perez ◽  
Adam Klipfel ◽  
Nishit Shah ◽  
Matthew Vrees ◽  
...  
Keyword(s):  
Phase I ◽  
Anal Cancer ◽  
Protein Targeting ◽  
Primary Tumour ◽  
Distant Metastases ◽  
Transformed Cells ◽  
Treatment Schedule ◽  
Hpv Dna ◽  
Oncology Research ◽  
Cell Immunity

Background Human papillomavirus (HPV) DNA is present in the majority of squamous cell cancers of the anus. ADXS11–001 immunotherapy is a live attenuated Listeria monocytogenes (Lm) bioengineered to secrete an HPV-16-E7 fusion protein targeting HPV-transformed cells. The Lm vector infects antigen-presenting cells, stimulating both MHC class 1 and 2 pathways resulting in specific T-cell immunity to tumours. The Brown University Oncology Research Group has initiated a phase I/II study evaluating two treatment schedules of ADXS11–001 with standard chemoradiation for anal cancer. Methods: Patients with newly diagnosed anal cancer with a primary tumour >4 cm or lymph node involvement, without distant metastases, are eligible. All patients receive two courses of mitomycin, 5-FU with concurrent radiation (54 Gy in 30 fractions by IMRT). Patients receive four treatments of ADXS11–001, 1 × 109 colony-forming units intravenously once approximately every 28 days. In treatment schedule 1, the first dose is given before chemoradiation and the second to fourth doses are given every 28 days after completion of radiation. In treatment schedule 2, the second dose of ADXS11–001 is administered during chemoradiation. Results: Three patients have been treated with ADXS11–001 and chemoradiation on treatment schedule 1. One patient developed grade 3 chills and one patient experienced grade 2 flu-like symptoms post-infusion, both resolved with symptomatic treatment. Conclusions: ADXS11–001 is a highly novel form of immunotherapy designed to generate an immune response against HPV transformed cells. Accrual is continuing to evaluate safety and efficacy for patients with anal cancer.

scholarly journals Prognostic impact of immunohistopathologic features in definitive radiation therapy for nasopharyngeal cancer patients

2019 ◽  
Vol 61 (1) ◽  
pp. 161-168 ◽  
Author(s):  
Naoya Murakami ◽  
Taisuke Mori ◽  
Yuko Kubo ◽  
Seiichi Yoshimoto ◽  
Kimiteru Ito ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Cancer Patients ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Nasopharyngeal Cancer ◽  
Intensity Modulated Radiation Therapy ◽  
Progression Free Survival ◽  
Immunohistochemical Analysis ◽  
Prognostic Impact ◽  
Biological Difference

ABSTRACT Our previous study by Murakami N, Mori T, Nakamura S, Yoshimoto S, Honma Y, Ueno T, Kobayashi K, Kashihara T, Takahashi K, Inaba K, Okuma K, Igaki H, Nakayama Y, Itami J. (J Radiat Res. 2019 Jul 30. pii: rrz053. doi: 10.1093/jrr/rrz053. [Epub ahead of print]) showed that strong expression of epithelial cell adhesion molecule (EpCAM) was associated with radiation resistance in head and neck squamous cell cancer patients (SCC). In this study, the prognostic impact of histopathologic features including EpCAM for nasopharyngeal cancer (NPC) patients was investigated. Since 2009, our institution has performed chemoradiation for locally advanced NPC patients with intensity modulated radiation therapy (IMRT). Tri-weekly adjuvant cisplatin (CDDP, 80 mg/m2) was administered concurrently with definitive radiation therapy 70 Gy in 35 fractions. One month after radiation therapy, adjuvant chemotherapy of three cycles of CDDP/5 fluorouracil (5-FU) was administered. Using a pretreatment biopsy specimen, EBV-encoded small RNA in situ hybridization (EBER-ISH), EpCAM, p16 and p53 were assessed by immunohistochemical analysis. Between May 2009 and September 2017, 51 NPC patients received definitive radiation therapy. Five, 13, 17 and 16 patients were staged as I, II, III and IV, respectively. The median follow-up period for alive patients was 31.1 months (12.4–109.7 months). Three-year overall survival (OS), progression-free survival (PFS) and locoregional control (LRC) were 87.1, 57.1 and 85.7%, respectively. EpCAM, p16 and p53 were not associated with PFS, OS nor LRC. Three-year PFS for patients with keratinizing and non-keratinizing SCC were 25 and 60.5%, respectively (P = 0.033, hazard ratio 4.851 (95% confidence interval 1.321–17.814)).Prognosis of NPC patients with keratinizing SCC was worse than non-keratinizing SCC patients, suggesting a biological difference between the two types of tumor.

Definitive Chemoradiation with Concurrent Weekly Cisplatin in the Treatment of Esophageal Squamous Cell Carcinoma – A Simplistic Approach

2021 ◽  
Vol 6 (2) ◽  
pp. 181-187
Author(s):  
Imtiaz Ahmed ◽  
Sapna Krishnamurthy ◽  
Rohan Bhise
Keyword(s):  
Squamous Cell ◽  
Treatment Time ◽  
Univariate Analysis ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Complete Response ◽  
Response To Treatment ◽  
Prolonged Treatment ◽  
Weekly Chemotherapy ◽  
Weekly Cisplatin

Purpose: Chemoradiation is the standard of care in locally advanced/ inoperable esophageal squamous cell cancer (ESCC). Though combination chemotherapy with Cisplatin and 5-Fluorouracil is the standard, it has low compliance due to toxicities and prolonged treatment time. Hence there is a window of opportunity to explore a safer chemotherapy regimen without compromising the treatment outcome. Methods: 55 patients of ESCC who were treated with definitive External Beam Radiotherapy (EBRT) to a dose of 50.4 – 59.4 Gray and concurrent weekly Cisplatin (or Carboplatin) were retrospectively evaluated for treatment efficacy and outcomes. 2 year Overall Survival (OS) and Progression Free Survival (PFS) were evaluated. Prognostic variables were assessed with respect to OS in Univariate analysis. Results: Median age at presentation was 58 years. 29 (53%) had lesion in the upper third of esophagus. 40 (72%) had T3 disease and 31 (56%) were node positive. All patients (100%) completed planned radiotherapy dose. 54 (98%) received 4 or more cycles of weekly chemotherapy. Mean overall treatment time was 43 days. Only 7 patients (12.7%) had grade 3 or more acute toxicity. 36 (65.5%) had complete response. At median follow-up of 13.7 months, the median OS was 15.2 months and 2 year OS was 42.6%. On univariate analysis, patients with comorbidities and lower third lesion had poor OS (p=0.016 and p=0.002). Stage II disease and complete response to treatment showed better OS (p=0.02 and p=0.00). Conclusion: Radical chemoradiation with weekly Cisplatin in ESCC is a simple and effective regimen which needs to be explored in larger trials.

Investigate the efficacy of immunotherapy for treatment of pancreatic adenocarcinoma (PDAC) with mismatch repair deficiency (dMMR).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 415-415
Author(s):  
Arish Noor ◽  
Luis E. Aguirre ◽  
Kirsten Blue ◽  
Trenton Avriett ◽  
Estrella M. Carballido ◽  
...  
Keyword(s):  
Pancreatic Adenocarcinoma ◽  
Metastatic Disease ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Complete Response ◽  
Median Number ◽  
Cancer Center ◽  
Duration Of Response

415 Background: Immune checkpoint inhibitors (ICI) have been approved in solid tumors with dMMR. However, only limited data are available for PDAC with dMMR given the rarity of dMMR in PDAC. We evaluated efficacy of ICIs in PDAC with dMMR. Methods: Retrospective clinical and pathologic data were collected for patients (pts) with pancreatic adenocarcinoma from May 2017 to June 2020 at Moffitt cancer center. Results: We identified 10 pts with dMMR PDAC. The median age was 64.5 years (range: 42-86) and 4 pts were male. 4 pts had resectable disease, 3 had locally advanced and 3 had metastatic disease at initial diagnosis. MSH6 deficiency (def) was found in 2 cases, PMS2 def in 2, MLH/PMS2 def in 5, and MSH2/MSH6 in 1. 7 pts were treated with ICIs. 3 pts had locally advanced and 4 had metastatic disease when they started ICIs. 5 received Pembrolizumab (pem), 1 received ipilimumab/ nivolumab (ipi/nivo), and 1 received pem then ipi/nivo after progressive disease (PD) on pem. The median number of prior lines of chemotherapy was 1 (range 0-2). 6 pts were evaluable, and 1 had rapid disease progression after 1 dose of pem. Among 6 evaluable pts, 3 had an objective response (1: complete response and 2: partial response), and 2 had stable disease (SD). Median progression-free survival was 8.2 mo, and median overall survival was not reached with median follow-up (FU) of 6.8 mo. The median duration of response was not reached with a median FU of 22.6 mo. The pt with CR remained disease-free for up to 22 months. The pt whose treatment was switched to ipi/nivo after PD on pem achieved SD > 4mo on ipi/nivo. While on immunotherapy, one patient with ipi/nivo developed immunotherapy associated rash requiring systemic steroids, and another on pem developed hypothyroidism requiring levothyroxine. Conclusions: This series suggest ICIs can provide durable clinical efficacy in pts with dMMR PDAC.

scholarly journals Long-term efficacy of imatinib mesylate in patients with advanced Tenosynovial Giant Cell Tumor

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
F. G. M. Verspoor ◽  
M. J. L. Mastboom ◽  
G. Hannink ◽  
R. G. Maki ◽  
A. Wagner ◽  
...  
Keyword(s):  
Giant Cell ◽  
Imatinib Mesylate ◽  
Locally Advanced ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Complete Response ◽  
The United States ◽  
Long Term Effects ◽  
Giant Cell Tumors

Abstract Tenosynovial giant cell tumors (TGCT), are rare colony stimulating factor-1(CSF-1)-driven proliferative disorders affecting joints. Diffuse-type TGCT often causes significant morbidity due to local recurrences necessitating multiple surgeries. Imatinib mesylate (IM) blocks the CSF-1 receptor. This study investigated the long term effects of IM in TGCT. We conducted an international multi-institutional retrospective study to assess the activity of IM: data was collected anonymously from individual patients with locally advanced, recurrent or metastatic TGCT. Sixty-two patients from 12 institutions across Europe, Australia and the United States were identified. Four patients with metastatic TGCT progressed rapidly on IM and were excluded for further analyses. Seventeen of 58 evaluable patients achieved complete response (CR) or partial response (PR). One- and five-year progression-free survival rates were 71% and 48%, respectively. Thirty-eight (66%) patients discontinued IM after a median of 7 (range 1–80) months. Reported adverse events in 45 (78%) patients were among other edema (48%) and fatigue (50%), mostly grade 1–2 (89%). Five patients experienced grade 3–4 toxicities. This study confirms, with additional follow-up, the efficacy of IM in TGCT. In responding cases we confirmed prolonged IM activity on TGCT symptoms even after discontinuation, but with high rates of treatment interruption and additional treatments.

scholarly journals Neoadjuvant radiotherapy in the approach of locally advanced breast cancer

ESMO Open ◽  
2020 ◽  
Vol 5 (2) ◽  
pp. e000640 ◽  
Author(s):  
Cláudia Sousa ◽  
Mafalda Cruz ◽  
Ana Neto ◽  
Kayla Pereira ◽  
Marta Peixoto ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Complete Response ◽  
Intrinsic Subtype ◽  
Advanced Breast ◽  
Neoadjuvant Radiotherapy ◽  
The Impact

BackgroundApproximately 4% of European patients are diagnosed with locally advanced breast cancer (LABC), a clinical condition commonly associated with poorer prognosis. Systemic therapy is the recommended initial treatment and when inoperability criteria prevails, radiotherapy (RT) should be used for tumour downstaging. This study intends to evaluate the impact of neoadjuvant radiotherapy (NART) in the treatment of inoperable LABC.MethodsA retrospective study of female patients, submitted to the NART between January 2014 and December 2018 at our institution. The evaluation of pathological response (pR) was made based on Pinder criteria. Primary endpoint: pR. Secondary endpoints: overall survival (OS) and progression-free survival (PFS). OS and PFS were calculated using the Kaplan-Meier method. Differences between groups were compared using Student’s t-test, ANOVA (Analysis of variance) and χ2 test. The statistical analyses were performed using Stata (V.13).ResultsA total of 76 patients were included, 18% with breast complete response. The 5 years OS was 54% and PFS was 61%. Subgroup analysis showed that pR >90% is correlated with a better OS (p=0.004). Basal-like intrinsic subtype is correlated with worse OS and PFS (p<0.05). No relation was found between response and age, intrinsic subtype, treatment performed and clinical T stage.ConclusionOur study confirms that NART is an effective downsizing treatment in inoperable LABC, allowing for a surgical resection regardless of the systemic treatment performed. Response to NART is independent of the intrinsic subtype and pR >90% is correlated with a better OS. Prospective studies to explore predictive response biomarkers are necessary in order to improve patient selection and optimisation of the treatment.

Circulating Human Papillomavirus DNA as a Biomarker of Response in Patients With Locally Advanced Cervical Cancer Treated With Definitive Chemoradiation

2018 ◽  
pp. 1-8 ◽  
Author(s):  
Kathy Han ◽  
Eric Leung ◽  
Lisa Barbera ◽  
Elizabeth Barnes ◽  
Jennifer Croke ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Fdg Pet ◽  
Residual Disease ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Advanced Cervical Cancer ◽  
Free Survival ◽  
Hpv Dna ◽  
Locally Advanced Cervical Cancer ◽  
Undetectable Plasma

Purpose To determine whether plasma human papillomavirus (HPV) DNA predates clinical recurrence and compare its accuracy with 3-month fluorodeoxyglucose positron emission tomography (FDG-PET) in locally advanced cervical cancer. Methods This prospective multicenter study accrued 23 women with stage IB to IVA cervical cancer planned for definitive chemoradiation therapy (CRT). Plasma HPV DNA was measured serially by digital polymerase chain reaction, and FDG-PET was performed at 3 months post-CRT. Results Of the 19 women with HPV+ cervical cancer included in this analysis, 32% were stage IB, 58% IIB, and 10% IIIB/IVA. Median follow-up was 24 months (range, 18 to 30 months). All patients had detectable plasma HPV DNA before treatment. Six patients had detectable plasma HPV DNA at the end of CRT, and three of them developed metastases at 3 months. Of the 13 patients with undetectable plasma HPV DNA at end of CRT, to date, only one has developed recurrence. Six of those 13 patients had a positive 3-month FDG-PET with no definite residual disease on subsequent imaging or clinical examination to date, and four of these six had undetectable plasma HPV DNA at 3 months. Patients with undetectable plasma HPV DNA at end of CRT had significantly higher 18-month progression-free survival than those with detectable plasma HPV DNA (92% v 50%; P = .02). The area under the receiver operating characteristic curve (accuracy) of 3-month plasma HPV DNA and 3-month FDG-PET imaging for predicting recurrence at 18 months were 77% and 60%, respectively ( P = .008). Conclusion Detectable plasma HPV DNA at end of CRT predates the clinical diagnosis of metastases and is associated with inferior progression-free survival. Moreover, 3-month plasma HPV DNA level is more accurate than 3-month FDG-PET imaging in detecting residual disease. The clinical utility of plasma HPV DNA detection for guiding adjuvant/salvage therapy should be evaluated in future studies.

scholarly journals Cisplatin, Cetuximab, and Radiation in Locally Advanced Head and Neck Squamous Cell Cancer: A Retrospective Review

2015 ◽  
Vol 9 ◽  
pp. CMO.S18682 ◽  
Author(s):  
Prakash Peddi ◽  
Runhua Shi ◽  
Binu Nair ◽  
Fred Ampil ◽  
Glenn M. Mills ◽  
...  
Keyword(s):  
Head And Neck ◽  
Performance Status ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Rank Test ◽  
Advanced Head ◽  
Significant Difference ◽  
Group A ◽  
Group B

Efficacy of cisplatin versus cetuximab with radiation in locally advanced head and neck cancer (LAHNC) was evaluated. A total of 96 patients with newly diagnosed LAHNC treated at our institution between 2006 and 2011 with concurrent radiation and cisplatin (group A, n = 45), cetuximab (group B, n = 24), or started with cisplatin but switched to cetuximab because of toxicity (group C, n = 27) were reviewed. Chi-square test, analysis of variance, and log-rank test were used for analysis. The three groups had similar baseline characteristics, except for median age, T stage, albumin levels, hemoglobin levels, performance status, and comorbidities. A complete response (CR) was seen in 77%, 17%, and 67% of patients ( P < 0.001), respectively. There was no significant difference in median overall survival (OS) between groups A and C. The median OS for groups A and C was not reached (>65 months), even though it was significantly longer than median OS for group B (11.6 months; P ≤ 0.001). The 2-year OS in groups A and C is significantly higher than that in group B (70% for groups A and C, 22% for group B). There is no significant difference in progression-free survival (PFS) between groups A and C. The median PFS for these groups was not reached (>62 months), and is significantly longer than that for group B (4.3 months; P ≤ 0.001). The 2-year PFS of group A (67%) and group C (76%) was significantly longer than that of group B (20%). Cisplatin with radiation appears to be more efficacious even in suboptimal dosing than cetuximab with radiation in LAHNC but the two groups were not well matched.

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