A phase III randomized study comparing cisplatin and fluorouracil as single agents and in combination for advanced squamous cell carcinoma of the head and neck.

1992 ◽  
Vol 10 (2) ◽  
pp. 257-263 ◽  
Author(s):  
C Jacobs ◽  
G Lyman ◽  
E Velez-García ◽  
K S Sridhar ◽  
W Knight ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Response Rate ◽  
Performance Status ◽  
Randomized Study ◽  
Dose Intensity ◽  
Phase Iii ◽  
Hematologic Toxicity ◽  
Significant Difference

PURPOSE To determine whether combination chemotherapy is superior to single agents for recurrent/metastatic head and neck cancer, we compared the efficacy and toxicity of cisplatin (CP) and fluorouracil (5-FU), alone and in combination in a phase III trial. PATIENTS AND METHODS Two hundred forty-nine patients with recurrent head and neck cancer were randomized to one of three treatments: CP (100 mg/m2) and 5-FU (1 g/m2 x 4), CP, or 5-FU every 3 weeks. RESULTS The overall response rate to the combination (32%) was superior to that of CP (17%) or 5-FU (13%) (P = .035). Response was associated with good performance status (PS) but not with primary site, site of recurrence, histology, prior irradiation, or relative dose intensity. Median time to progression was less than 2.5 months, and there was no significant difference in median survival (5.7 months) among the groups. By multivariate analysis, patients with better PS and poorly differentiated tumors had superior survival. Hematologic toxicity and alopecia were worse in the combination arm. CONCLUSION Although the response rate to the combination of CP plus 5-FU was superior to that achieved with single agents, survival did not improve.

Radiation and Concurrent Carboplatin Administration in Locally Advanced Head and Neck Cancer

1995 ◽  
Vol 81 (5) ◽  
pp. 354-358 ◽  
Author(s):  
◽  
George Fountzilas ◽  
Dimosthenis Skarlos ◽  
Angelos Nikolaou ◽  
Anna Kalogera-Fountzila ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Performance Status ◽  
Combined Treatment ◽  
Locally Advanced ◽  
Dose Intensity ◽  
Phase Iii ◽  
Concurrent Administration ◽  
Grade 3

Aims and Background To improve local control in patients with locally advanced inoperable head and neck cancer we administered carboplatin concurrently with radiation. Methods Thirty-nine patients entered the study. There were 35 men and 4 women with a median age of 58 years (range, 24-74) and a median performance status of 90 (range, 60-100) of the Karnofsky scale. The primary site included nasopharynx (5 patients), oropharynx (n=10), hypopharynx (n=5), larynx (n=12), oral cavity (n=2), paranasal sinuses (n=3), salivary glands (n=1) and unknown (n=1). Histology was squamous cell carcinoma in all cases. All patients were irradiated with a 60Co unit. According to the protocol, they should receive 66-70 Gy to the tumor area and 45 Gy to the tumor-free area of the neck. Carboplatin was administered at a dose of 400 mg/m2 on days 2, 22 and 42. Results Totally, 112 cycles of carboplatin were administered, of which 106 (95%) were at full dose. Median dose intensity of carboplatin actually delivered was 170 mg/m2/week (range, 57-200). All patients were irradiated, although only 30 (77%) received >66 Gy. After the completion of combined treatment, 23 (59%, 95% C.I. 42-74%) achieved a CR and 10 (26%, 95% C.I. 13-42%) a PR. Grade 3-4 myelotoxicity was noticed in 60% of the patients. Other grade 3-4 toxicities included stomatitis (13%), dysphagia (5%) and weight loss (3%). Median time to progression was 18 months (range, 2-25). Conclusions Radiation and concurrent administration of carboplatin determined a high CR rate in patients with HNC, although the superiority of this combined modality approach over radiation alone has to be proven in phase III trials.

scholarly journals TO COMPARE THE TOXICITY PROFILE OF ACCELERATED RADIOTHERAPY (SIX FRACTIONS PER WEEK) WITH CONCOMITANT CHEMO-RADIOTHERAPY IN LOCALLY ADVANCED HEAD AND NECK CANCER

2019 ◽  
Vol 3 (11) ◽  
Author(s):  
Vikrant Kaushal ◽  
Amit Rana ◽  
Manoj Gupta ◽  
Rajeev Seam ◽  
Manish Gupta
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Randomized Study ◽  
Locally Advanced ◽  
Medical Science ◽  
Hematological Toxicity ◽  
P Value ◽  
Significant Difference ◽  
The Difference

Background: Head and neck malignancies are common among males in India. The age adjusted incidence rate of head and neck cancer in India in males is 16.4/100,000 and in females it is 8.8/100,000.In All India Institute of Medical Science head and neck cancer represents 25% of all malignancies registered Methods: This prospective randomized study was conducted in the Department of Radiation Therapy & Oncology, Regional Cancer Centre, IGMC, Shimla and patients were enrolled for a period of one year, from July 2012 to July 2013.It included all the eligible, previously untreated patients of squamous cell carcinoma of Head and Neck with histologically confirmed diagnosis and no evidence of distant metastasis. The sites included were oro-pharynx, hypo-pharynx and larynx with stages III, IV A and IV B. Results: Grade 3 and grade 4 skin toxicities were higher in CRT arm but without statistically significant difference from that in ART arm. G3 & G4 mucositis was higher in the Concomitant CRT arm however the difference was not statistically significant. G2 and G3 Laryngeal Toxicities were higher in Concomitant CRT arm as compared to Accelerated arm but the difference was not statistically significant. G2 & G3 haematological toxicities were significantly (combined p value = 0.002) higher in the concomitant CRT arm (32.4%) as compared to Accelerated RT arm (2.9%). Only one patient in accelerated arm had any hematological toxicity. Conclusion: Higher peak incidence of toxicities was seen in concomitant CRT arm as compared to accelerated arm. Keywords: Toxocity, six fraction, chemoradiation, Local control

A phase III randomized clinical trial of diclofenac versus tramadol for mucositis-related pain in head and neck cancer patients undergoing concurrent chemoradiation.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24124-e24124
Author(s):  
Sachin Babanrao Dhumal ◽  
Vanita Noronha ◽  
Vijay Maruti Patil ◽  
Amit Joshi ◽  
Nandini Sharrel Menon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Head And Neck Cancer ◽  
Adverse Events ◽  
Head And Neck ◽  
Renal Dysfunction ◽  
Cancer Patients ◽  
Neck Cancer ◽  
Phase Iii ◽  
Controlled Study ◽  
Significant Difference

e24124 Background: Oral mucositis related pain during CTRT in head and neck cancers is a common problem. Unfortunately, in spite of it being common, there is limited evidence for selection of systemic analgesic in this situation. Hence, this study was designed to compare the analgesic effect of an NSAID (diclofenac) versus a weak opioid (tramadol). Methods: This was an open-label, parallel design, superiority randomized controlled study. In this study head and neck cancer patients undergoing radical or adjuvant chemoradiation, who had grade 1 or above mucositis (in accordance with CTCAE version 4.03) and had pain related to it were randomly assigned to either diclofenac or tramadol for mucositis related pain control. The primary endpoint was analgesia after the 1st dose. The secondary endpoints were the rate of change in analgesic within 1 week, adverse events, and quality of life. Results: 128 patients were randomized, 66 in diclofenac and 62 in tramadol arm. The median AUC for the diclofenac arm and the tramadol arm were 348.936 units (Range 113.64-1969.23) & 420.87 (101.97-1465.96) respectively (p = 0.05619). Five patients (8.1%) in the tramadol arm and 11 patients (16.7%) in the diclofenac arm required a change in analgesic within 1 week of starting the analgesic (p = 0.184). There was no statistically significant difference in any adverse events between the 2 arms. However, the rate of any grade of renal dysfunction was numerically higher in diclofenac arm (10.6% versus 4.8%, p = 0.326). Conclusions: In this phase 3 study, evaluating diclofenac and tramadol for Chemoradiation induced mucositis pain, the analgesic efficacy of both analgesics was found to be similar but diclofenac was associated with a higher rate of renal dysfunction. Clinical trial information: CTRI/2016/09/007302 .

Functional status after total laryngectomy: cross-sectional survey of 79 laryngectomees using the Performance Status Scale for Head and Neck Cancer

2009 ◽  
Vol 124 (4) ◽  
pp. 412-416 ◽  
Author(s):  
N B Oozeer ◽  
S Owen ◽  
B Z Perez ◽  
G Jones ◽  
A R Welch ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Standard Deviation ◽  
Head And Neck ◽  
Neck Cancer ◽  
Total Laryngectomy ◽  
Performance Status ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Significant Difference ◽  
Performance Status Scale

AbstractIntroduction:Total laryngectomy affects patients' post-operative speech and swallowing functions. We aimed to assess these outcomes.Materials and methods:Patients' normalcy of diet, ability to eat in public and speech comprehensibility were assessed using the Performance Status Scale for Head and Neck Cancer, in a cross-sectional survey of disease-free laryngectomees.Results and analysis:Seventy-nine laryngectomees (72 men and seven women), with a mean age of 64 years (range 37 to 96), were included. Mean scores were 81.6 (standard deviation 29.2) for normalcy of diet, 77.8 (standard deviation 30.2) for eating in public and 65.2 (standard deviation 23.5) for speech. Normalcy of diet achieved higher scores within six months of laryngectomy and remained stable. There was a statistically significant difference between scores for the speech and public eating domains, comparing patients less and more than six months post-laryngectomy. This trend was maintained beyond 12 months.Conclusions:In post-laryngectomy patients, Performance Status Scale for Head and Neck Cancer scores improved over time, especially those for the speech and public eating domains, reflecting increasing confidence in social interactions and familiarity with surgical voice restoration.

Placebo-controlled randomized trial of infusional fluorouracil during standard radiotherapy in locally advanced head and neck cancer.

1994 ◽  
Vol 12 (12) ◽  
pp. 2648-2653 ◽  
Author(s):  
G P Browman ◽  
C Cripps ◽  
D I Hodson ◽  
L Eapen ◽  
J Sathya ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Response Rate ◽  
Complete Response Rate ◽  
Performance Status ◽  
Locally Advanced ◽  
Eastern Cooperative Oncology Group ◽  
Complete Response ◽  
Survival Duration

PURPOSE To determine whether the addition of infusional fluorouracil (I-FU) to standard radiotherapy improves survival at acceptable toxicity in patients with locally advanced squamous cell head and neck cancer (SCHNC). PATIENTS AND METHODS Consenting patients with an Eastern Cooperative Oncology Group (ECOG) performance status < or = 2; with stage III or IV SCHNC of the oral cavity, oropharynx, hypopharynx, or larynx; and who were recommended for radiotherapy with curative intent received 66 Gy of radiation therapy delivered in 2-Gy fractions once daily 5 days per week for 6 1/2 weeks. Those in the experimental arm received I-FU 1.2 g/m2/d, as a 72-hour infusion in the first and third weeks of radiation. Saline infusions were used in the placebo arm. RESULTS One hundred seventy-five patients were randomized (88 to I-FU and 87 to placebo), and the treatment arms were well balanced. The complete response rate was 68% for I-FU and 56% for placebo (P = .04). The overall median survival duration was 33 months for I-FU and 25 months for placebo (P = .08). Progression-free survival also favored I-FU (P = .06). Toxicity was greater in I-FU patients, but did not interfere with the scheduled delivery or completion of radiation. CONCLUSION The addition of I-FU to standard radiation in SCHNC improved the complete response rate and was associated with beneficial trends in progression-free and overall survival compared with radiation alone. I-FU patients also experienced greater morbidity, but this did not compromise delivery of radiotherapy.

Subcutaneous Compared With Intravenous Administration of Amifostine in Patients With Head and Neck Cancer Receiving Radiotherapy: Final Results of the GORTEC2000-02 Phase III Randomized Trial

2011 ◽  
Vol 29 (2) ◽  
pp. 127-133 ◽  
Author(s):  
Etienne Bardet ◽  
Laurent Martin ◽  
Gilles Calais ◽  
Marc Alfonsi ◽  
Nasr Eddine Feham ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Acute Toxicity ◽  
Head And Neck ◽  
Neck Cancer ◽  
Linear Mixed Model ◽  
Radiation Therapy Oncology Group ◽  
Salivary Flow ◽  
Phase Iii ◽  
Flow Rates ◽  
Significant Difference

Purpose To compare compliance with and efficacy of intravenous (IV) and subcutaneous (SC) amifostine for the treatment of patients undergoing radiotherapy for head and neck cancer. Patients and Methods Patients with newly diagnosed squamous cell carcinoma of the head and neck, who were eligible for radiotherapy and who were not receiving concurrent chemotherapy, were randomly assigned to receive either IV amifostine (200 mg/m2 daily for 3 minutes, 15 to 30 minutes before irradiation) or SC amifostine (500 mg; two sites; 20 to 60 minutes before irradiation). The primary end point was late xerostomia at 1 year as indicated by unstimulated and stimulated salivary flow rates, a patient benefit questionnaire score, and Radiation Therapy Oncology Group (RTOG) late toxicity grade. Results Results for IV (n = 143) versus SC (n = 148) administration were as follows. There was no significant difference in compliance (69% for IV v 71% for SC) in patients receiving a full dose of amifostine. Reasons for dose reduction were acute toxicity (25% for IV v 27% for SC; P = .51) and logistics (18% for IV v 9% for SC administration; P = .09). Acute toxicity differed significantly in terms of grade 1 to 2 hypotension (19% for IV v 8% for SC; P = .01), grade 1 to 2 skin rash (9% for IV v 21% for SC; P = .01), and local pain (0% for IV v 8% for SC; P = .003). The incidence of grade 2 or greater xerostomia was significantly higher for patients who received amifostine via SC administration (37% for IV v 62% for SC; P = .005) in the 127 patients (n = 67, IV; n = 60, SC) evaluable at 1 year but not at 2 or 3 years (36% for IV v 51% for SC administration; P = .19; 32% for IV v 41% for SC; P = .63). A generalized linear mixed-model analysis of all data revealed no significant difference in patient self-assessment of salivary function (P = .25), unstimulated or stimulated salivary flow rates (P = .054 and .82, respectively), or grade 2 or greater xerostomia (P = .23). Conclusion SC amifostine administration was not significantly superior to IV amifostine administration in terms of patient compliance or efficacy.

scholarly journals Activity of combined gemcitabine therapy on treatment of planocellular carcinoma: A pilot study

2004 ◽  
Vol 12 (2) ◽  
pp. 109-111
Author(s):  
Danijela Scepanovic ◽  
Nada Bajic ◽  
Jovan Babic
Keyword(s):  
Lung Cancer ◽  
Head And Neck Cancer ◽  
Pilot Study ◽  
Head And Neck ◽  
Cancer Patients ◽  
Neck Cancer ◽  
Response Rate ◽  
Chemotherapy Group ◽  
Radiotherapy Group ◽  
Significant Difference

BACKGROUND: Drug-orientated, pilot study was conducted to estimate the activity of gemcitabine on treatment of head and neck and lung planocellular carcinoma in combination with either radiotherapy or chemotherapy. METHODS There were 22 patients treated with gemcitabine for planocellular carcinoma of head and neck (9 patients) and lung (13 patients). Combined gemcitabine-radiotherapy was applied in 10 patients while gemcitabine-chemotherapy in 12 patients. Eligible and evaluable patients (22) were with either locally advanced (14 patients) or metastatic (8 patients) stage of the disease. In gemcitabine-radiotherapy group, gemcitabine was given IV, 1000 mg/ m2, on day 1, 8, and 15 during the radiotherapy course as radiopotentiator (65 Gy in 32 fractions for head and neck, and 55 Gy in 20 fractions, split course one month for lung cancer patients). In gemcitabine-chemotherapy group the same dose of gemcitabine was given (4-week schedule) in combination with platinum based cytotoxic drugs. We analyzed response rate and toxicity. RESULTS: Among patients treated for head and neck planocellular carcinoma, there were 67% complete responders while there was 15% complete responders treated for lung cancer. Also, 80% of patients treated in gemcitabine-radiotherapy group had complete response while 50% of those treated in gemc- itabine-chemotherapy group. Actuarial survival as function of tumor control was 52% for lung and 88% for head and neck cancer 12 months after the initiation of treatment. In gemcitabine-radiotherapy group of patients treated for head and neck carcinoma, the radiation mucositis grade III was observed in 80% while in gemcitabine - chemotherapy group of patients the most common side effect (60% of patients) was neutropenia grade II (40%)/III (20%). CONCLUSION: There was no statistically significant difference regarding response rate between two groups of patients (head and neck vs. lung cancer, and gemcitabine- radiotherapy vs. gemcitabine - chemotherapy). However, better clinical results were achieved for head and neck cancer patients, particularly in gemcitabine - radiotherapy group but with significant toxicity due to high gemcitabine dose.

scholarly journals Clinical and radiobiological comparison of two palliative regimens of radiotherapy in advanced squamous cell carcinoma of head and neck: a prospective randomized study

1970 ◽  
Vol 17 (1) ◽  
pp. 29-35
Author(s):  
Debabrata Mitra ◽  
Kakali Choudhury ◽  
Md Abdur Rashid
Keyword(s):  
Squamous Cell Carcinoma ◽  
Head And Neck Cancer ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Neck Cancer ◽  
Squamous Cell ◽  
Randomized Study ◽  
Advanced Head ◽  
Advanced Squamous Cell Carcinoma ◽  
Significant Difference

Objective: The aim of this study is to compare two different palliative radiotherapy regimes - standard hypofractionated regime and split course hypofractionated regime in advanced head and neck cancer.  Methods: 60 untreated patients of advanced squamous cell carcinoma of head and neck who were treated with palliative intent were randomized into two arms: Arm A (n=30) patients received 30 Gy in 10 fractions in two weeks; Arm B (n=30) patients received 1750 cGy in 5 fractions followed by a three weeks gap and then again 1750 cGy in 5 fractons, treatment completed in 5 weeks. Result: The response was comparable in both the arms. Symptom palliation was also similar; pain relief was 76% in both arms and relief of dysphagia 73% in arm A vs 79% in arm B. Partial response rate was equivalent (69% vs 62%). Mucositis and upper GI toxicity did not show any significant difference. Patient drop out was only 1 in arm B compared to 4 in arm A. The BED10 values are 39 and 37.84 in arm A and B respectively; whereas the BED3 values are 60 and 75.8. Conclusion: We conclude that the second regime can also be used in palliative setting in some selected patients. Key words: Advanced head and neck cancer; Palliative Radiation. DOI: 10.3329/bjo.v17i1.7620 Bangladesh J Otorhinolaryngol 2011; 17(1): 29-35

scholarly journals Swedish National Multicenter Study on Head and Neck Cancer of Unknown Primary: Prognostic Factors and Impact of Treatment on Survival

2020 ◽  
Author(s):  
Lars Axelsson ◽  
Erik Holmberg ◽  
Jan Nyman ◽  
Anders Högmo ◽  
Helena Sjödin ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Prognostic Factors ◽  
Head And Neck ◽  
Neck Dissection ◽  
Neck Cancer ◽  
Multicenter Study ◽  
Performance Status ◽  
Cancer Of Unknown Primary ◽  
Unknown Primary ◽  
N Stage

Abstract Introduction Head and neck cancer of unknown primary (HNCUP) is a rare condition whose prognostic factors that are significant for survival vary between studies. No randomized treatment study has been performed thus far, and the optimal treatment is not established. Objective The present study aimed to explore various prognostic factors and compare the two main treatments for HNCUP: neck dissection and (chemo) radiation vs primary (chemo) radiation. Methods A national multicenter study was performed with data from the Swedish Head and Neck Cancer Register (SweHNCR) and from the patients' medical records from 2008 to 2012. Results Two-hundred and sixty HNCUP patients were included. The tumors were HPV-positive in 80%. The overall 5-year survival rate of patients treated with curative intent was 71%. Age (p < 0.001), performance status (p= 0.036), and N stage (p= 0.046) were significant factors for overall survival according to the multivariable analysis. Treatment with neck dissection and (chemo) radiation (122 patients) gave an overall 5-year survival of 73%, and treatment with primary (chemo) radiation (87 patients) gave an overall 5-year survival of 71%, with no significant difference in overall or disease-free survival between the 2 groups. Conclusions Age, performance status, and N stage were significant prognostic factors. Treatment with neck dissection and (chemo) radiation and primary (chemo) radiation gave similar survival outcomes. A randomized treatment study that includes quality of life is needed to establish the optimal treatment.

Sign in / Sign up

Export Citation Format

Share Document