Concurrent chemotherapy practice patterns for head and neck cancer: What is standard of care?

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5542-5542
Author(s):  
S. J. Wong ◽  
Z. Agha ◽  
S. Milligan
Keyword(s):  
Head And Neck ◽  
Initial Dose ◽  
Low Dose ◽  
Single Agent ◽  
Locally Advanced ◽  
Standard Of Care ◽  
Prescribing Patterns ◽  
Phase Iii ◽  
High Dose ◽  
Community Based

5542 Background: The superiority of concurrent high dose cisplatin and radiation (RT) compared to RT alone for pts with locally advanced squamous cell cancer of the head and neck (SCCHN) has been demonstrated in large prospective phase III clinical trials. However, little is known regarding general prescribing patterns for chemotherapy (CT) utilization in combined modality treatment (CMT) for SCCHN. We conducted the present study to gain insight as to whether results from pivotal phase III trials affect utilization of concurrent CT in academic and community centers. Methods: We analyzed individual data from 326 SCCHN pts treated with concurrent CT and RT between 03/2003 and 12/2004 from 53 centers (43 community-based, 7 academic, and 3 VA or military) using electronically captured data from IntelliDose, a chemotherapy order software program. Results: Of 326 total pts, 123 pts (38%) received single agent cisplatin. From this group, 71 (58%) received low dose cisplatin (<74 mg/m2, mean initial dose 67 mg), while 52 patients (42%) received high dose cisplatin (≥ 74 mg/m2, mean initial dose 189 mg). 72 pts (22%) received carboplatin/paclitaxel, 60 pts (18%) received cisplatin /5FU, 18 pts (5.5%) received single agent carboplatin, while 6 pts (1.8%) received cetuximab either alone or in combination with cisplatin. Other infrequently used regimens (each < 5%) cumulatively accounted for 14% of pts treated. Comparison of chemotherapy utilization between academic and community-based practice centers showed no statistical difference with respect to use of high dose cisplatin versus low dose cisplatin, or single agent cisplatin versus non-cisplatin regimens. Conclusions: Despite evidence from phase III studies that concurrent high dose cisplatin is the standard of care for CMT of locally advanced SCCHN, utilization of other regimens, such as weekly low dose cisplatin, are commonly utilized. [Table: see text]

Phase III Comparison of High-Dose Paclitaxel + Cisplatin + Granulocyte Colony-Stimulating Factor Versus Low-Dose Paclitaxel + Cisplatin in Advanced Head and Neck Cancer: Eastern Cooperative Oncology Group Study E1393

2001 ◽  
Vol 19 (4) ◽  
pp. 1088-1095 ◽  
Author(s):  
Arlene A. Forastiere ◽  
Traci Leong ◽  
Eric Rowinsky ◽  
Barbara A. Murphy ◽  
Daniel R. Vlock ◽  
...  
Keyword(s):  
Head And Neck ◽  
Low Dose ◽  
Objective Response ◽  
Locally Advanced ◽  
Phase Iii ◽  
High Dose ◽  
Hematologic Toxicity ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Stimulating Factor

PURPOSE: To determine dose-response effects and the activity of paclitaxel combined with cisplatin in patients with incurable squamous cell carcinoma of the head and neck. PATIENTS AND METHODS: Two hundred ten patients with locally advanced, recurrent, or metastatic disease were randomly placed in either Arm A, paclitaxel 200 mg/m2 (24-hour infusion) + cisplatin 75mg/m2 + granulocyte colony-stimulating factor, or Arm B, paclitaxel 135 mg/m2 (24-hour infusion) + cisplatin 75 mg/m2. Cycles were repeated every 3 weeks until progression or a total of 12 cycles for complete responses. Primary outcomes were event-free and overall survival. RESULTS: No significant differences in outcomes were observed between the high- and low-dose paclitaxel regimens. The estimated median survival was 7.3 months (95% confidence interval, 6.0 to 8.6). The 1-year survival rate was 29%, and event-free survival was 4.0 months. The objective response rate (complete response plus partial response) was 35% for the high-dose patients and 36% for the low-dose patients. Myelosuppression was the most frequent toxicity: grade 3 or 4 granulocytopenia, 70% of patients in Arm A and 78% in Arm B; febrile neutropenia, 27% of patients in Arm A and 39% in Arm B. Grade 5 toxicities occurred in 22 patients (10.5%). Treatment was terminated early in 31% because of excessive toxicity or patient refusal. CONCLUSION: This phase III multicenter trial showed (1) no advantage for high-dose paclitaxel and (2) excessive hematologic toxicity associated with both regimens. Therefore, neither of the paclitaxel regimens evaluated in this trial can be recommended.

An Intergroup Phase III Comparison of Standard Radiation Therapy and Two Schedules of Concurrent Chemoradiotherapy in Patients With Unresectable Squamous Cell Head and Neck Cancer

2003 ◽  
Vol 21 (1) ◽  
pp. 92-98 ◽  
Author(s):  
David J. Adelstein ◽  
Yi Li ◽  
George L. Adams ◽  
Henry Wagner ◽  
Julie A. Kish ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Squamous Cell ◽  
Survival Data ◽  
Single Agent ◽  
Phase Iii ◽  
High Dose ◽  
Fractionated Radiation

Purpose: The Head and Neck Intergroup conducted a phase III randomized trial to test the benefit of adding chemotherapy to radiation in patients with unresectable squamous cell head and neck cancer. Patients and Methods: Eligible patients were randomly assigned between arm A (the control), single daily fractionated radiation (70 Gy at 2 Gy/d); arm B, identical radiation therapy with concurrent bolus cisplatin, given on days 1, 22, and 43; and arm C, a split course of single daily fractionated radiation and three cycles of concurrent infusional fluorouracil and bolus cisplatin chemotherapy, 30 Gy given with the first cycle and 30 to 40 Gy given with the third cycle. Surgical resection was encouraged if possible after the second chemotherapy cycle on arm C and, if necessary, as salvage therapy on all three treatment arms. Survival data were compared between each experimental arm and the control arm using a one-sided log-rank test. Results: Between 1992 and 1999, 295 patients were entered on this trial. This did not meet the accrual goal of 362 patients and resulted in premature study closure. Grade 3 or worse toxicity occurred in 52% of patients enrolled in arm A, compared with 89% enrolled in arm B (P < .0001) and 77% enrolled in arm C (P < .001). With a median follow-up of 41 months, the 3-year projected overall survival for patients enrolled in arm A is 23%, compared with 37% for arm B (P = .014) and 27% for arm C (P = not significant). Conclusion: The addition of concurrent high-dose, single-agent cisplatin to conventional single daily fractionated radiation significantly improves survival, although it also increases toxicity. The loss of efficacy resulting from split-course radiation was not offset by either multiagent chemotherapy or the possibility of midcourse surgery.

scholarly journals Optimizing Treatment for Head and Neck Cancers: Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

2020 ◽  
Vol 18 (7.5) ◽  
pp. 982-984
Author(s):  
Robert I. Haddad
Keyword(s):  
Head And Neck ◽  
Single Agent ◽  
Standard Of Care ◽  
Phase Iii ◽  
Routine Practice ◽  
Second Line ◽  
First Line ◽  
Positive Score ◽  
Combined Positive Score ◽  
Line Setting

Immunotherapy has changed the game in the treatment of head and neck cancer (HNC). Practice-changing results from the phase III KEYNOTE-048 trial led to the approval of pembrolizumab immunotherapy alone or in combination with chemotherapy for the treatment of recurrent/metastatic HNC in the first-line setting. Testing for combined positive score (CPS) is now part of routine practice, because patients with CPS ≥1 can be started on single-agent immunotherapy in the first-line. Pembrolizumab replaces the “old” standard of care established by the EXTREME study, as trials looking at targets besides immunotherapy have proved “disappointing.” Additionally, nivolumab and pembrolizumab are both approved for use in the second-line.

Dose escalation of radiotherapy (RT) for locally advanced head and neck carcinomas treated with concomitant chemotherapy (CT) and RT: Results of the GORTEC 2004-01 randomized trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6015-6015 ◽  
Author(s):  
Jean Bourhis ◽  
Anne Auperin ◽  
Marc Alfonsi ◽  
xu Shan Sun ◽  
Michel Rives ◽  
...  
Keyword(s):  
Head And Neck ◽  
Dose Escalation ◽  
Locally Advanced ◽  
Standard Of Care ◽  
Dose Effect ◽  
High Dose ◽  
Significance Level ◽  
Sequential Boost ◽  
Accrual Rate ◽  
New Evidence

6015 Background: Concomitant CT-RT is a well established standard of care (SoC) in locally advanced (LA) squamous cell carcinomas of the head and neck (SCCHN). While there is a well established dose effect relationship for RT alone in these cancers, it is not known whether this also applies to concomitant CT-RT. Methods: Patients were randomized between 75 Gy/7 weeks (Arm A) versus 70 Gy/35F in 7 weeks (Arm B). A sequential boost of 10 times 2.5 Gy after 50Gy/25F was given to the initial gross tumor volume (GTV) in Arm A. IMRT was used for arm A and 3D conformal RT for arm B. In both arms, patients (pts) received during RT 3 cycles of cisplatin at 100 mg/m2. Inclusion criteria were pts fit for receiving high dose cisplatin, non metastatic, non operated stage III-IV SCC of oral cavity, oro/hypopharynx. A 1:1 randomization was done by minimization on centers, N & T stages & GTV uni/bilateral. To detect a hazard ratio (HR) of 0.56 in locoregional (LR) control, inclusion of 310 pts was required to observe 109 LR progressions and achieve 85% power at 2-sided significance level of 0.05. Results: Between 2005 and 2015, 188 pts were randomized: 82% males, median age 58 years, 85% oropharynx. The accrual rate was slower than expected, due to the fact that IMRT became a SoC and was only allowed in arm A. As a consequence the trial was discontinued after inclusion of 188 patients. The majority of pts had stage IVa (73% vs 72%). All initial characteristics were well balanced between arms. The median follow-up was 4.7 years, not different between arms. Acute and late xerostomia were markedly improved in arm A (IMRT arm). The 1-year grade 0-1 salivary toxicity (RTOG) was 81% and 34% (p< 0.0001) in arm A and B respectively. At 3 years these rates were 92% vs 53% (p=0.0003). The increase of the dose to the GTV with IMRT did not transfer in a higher LR control probability with an adjusted HR of 0.88 [95%CI 0.51-1.52] (p=0.63). PFS, overall survival were not significantly different between the 2 arms. Conclusions: The dose escalation of RT to the GTV did not improve LR control in patients treated with concomitant CT-RT. This trial adds some new evidence level 1 in favor of IMRT in LA SCCHN. Clinical trial information: NCT00158678.

Carboplatin versus cetuximab chemoradiation in cisplatin ineligible locally advanced head and neck squamous cell carcinoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e18555-e18555
Author(s):  
Kannan Thanikachalam ◽  
Jayasree Krishnan ◽  
Farzan Siddiqui ◽  
Haythem Y. Ali ◽  
Jawad Sheqwara
Keyword(s):  
Head And Neck ◽  
Squamous Cell ◽  
Randomized Clinical Trials ◽  
Single Agent ◽  
Locally Advanced ◽  
Standard Of Care ◽  
Hpv Infection ◽  
Entire Group ◽  
P Value ◽  
Significant Difference

e18555 Background: Squamous cell carcinomas (SCC) of Head and neck are associated with tobacco, alcohol use and HPV infection. About 60% of patients with head and neck cancers(HNC) are locally advanced on diagnosis. Concurrent chemoradiation (CCRT) is standard of care in inoperable locally advanced HNC(LA-HNC), high risk adjuvant setting and organ function preservation. While cisplatin (CDDP) is the standard of care for CCRT, alternatives are carboplatin alone or cetuximab alone or carboplatin in combination with 5-FU or paclitaxel CCRT in CDDP ineligible setting. Methods: Patients with LA-HNC (SCC), from 01/01/2013-12/31/2018, who were ineligibile for CDDP CCRT and who received either carboplatin or cetuximab CCRT were included. Patients who received induction chemotherapy and had nasopharynx primary were excluded. 68 patients were analyzed to evaluate outcomes in patients who received carboplatin CCRT and cetuximab CCRT. Progression free survival (PFS) and Overall survival (OS) were calculated by Kaplan Meier analysis with SPSS v26. Results: There was a trend toward improved PFS in CarboRT group among oropharynx HNC patients who were P16 Negative(-ve) (59.5 months(m) vs 37.7 m, p value – 0.069). Among oropharynx HNC patients who were p16 positive, there was no statistically significant difference in PFS among CarboRT vs CetuximabRT (45.8 m vs. 39.77 m, p value – 0.51). OS was favorable towards carboRT in oropharynx SCC p16-ve group (59.5 m vs. 40.97 m, p value – 0.41). There was no difference in OS in p16+ve Oropharynx SCC group, who received CarboRT and CetuximabRT (45.74 vs. 45.94 m, p value – 0.77). When patients were analyzed regardless of their p16 status, site or stage, patients who received CarboRT had a higher OS at 56.30 m (95% CI 45.10-67.50%) vs. 38.11 m (95% CI 28.84-47.38%) among patients who received CetuximabRT (p value-0.048). Though PFS clinically favored carboRT group, when compared to CetuximabRT (55.43 m vs. 36.75 m), it was not statistically significant (p value – 0.10). Conclusions: In our analysis, patients who received single agent carboplatin CCRT had higher OS when compared to cetuximab CCRT. Though other outcomes favored carboplatinRT including PFS among entire group and p16-ve group, OS in p16-ve patients, it was not statistically significant, which is likely due to low power. Based on our analysis, for LA-HNC, carboplatin CCRT should be favored over cetuximab CCRT for patients ineligible for CDDP, particularly in P-16 -ve disease. Further randomized clinical trials can shed more data in this reduced intensity regimen.

Ototoxicity in a Randomized Phase III Trial of Intra-Arterial Compared With Intravenous Cisplatin Chemoradiation in Patients With Locally Advanced Head and Neck Cancer

2007 ◽  
Vol 25 (24) ◽  
pp. 3759-3765 ◽  
Author(s):  
Charlotte L. Zuur ◽  
Yvonne J. Simis ◽  
Pauline E. Lansdaal ◽  
Augustinus A. Hart ◽  
Jan H. Schornagel ◽  
...  
Keyword(s):  
Hearing Loss ◽  
Speech Perception ◽  
Head And Neck ◽  
Hearing Aids ◽  
Locally Advanced ◽  
Sodium Thiosulfate ◽  
Phase Iii ◽  
High Dose ◽  
Advanced Head ◽  
Treatment Protocols

Purpose Cisplatin concomitantly administered with radiotherapy is increasingly used in locally advanced head and neck squamous cell carcinoma. We aimed to compare the incidence of hearing loss between patients treated with intra-arterial high-dose cisplatin chemoradiation with sodium thiosulfate (CRT-IA) and intravenous high-dose cisplatin chemoradiation without sodium thiosulfate (CRT-IV). Patients and Methods We conducted a prospective analysis of hearing thresholds at low and (ultra-) high frequencies obtained before, during, and after treatment in 158 patients. Patients were randomly assigned for either CRT-IA (150 mg/m2, four courses) with sodium thiosulfate cisplatin neutralization or CRT-IV (100 mg/m2, three courses) without rescue. All patients received concomitant radiation therapy (RT; 70 Gy). Results CRT-IA resulted in approximately 10% less hearing loss at frequencies vital for speech perception, compared with CRT-IV (P < .001). In CRT-IA, fewer ears qualified for hearing aids (36% v 49%; P = .03). However, in both treatment arms, the incidence expressed in National Cancer Institute Common Terminology Criteria of Adverse Events (version 3) did not deviate (P > .14). Age, cumulative cisplatin dose, cumulative RT dose, and the considered frequency area determine the degree of hearing loss (P < .001). Cisplatin induced increasing hearing loss of 24% to 60% with increasing frequencies. RT induced hearing loss at speech frequencies of 9% to 12%. Conclusion Depending on the criteria used to assess hearing loss due to treatment, differences in ototoxicity between CRT-IA and CRT-IV were found in favor of CRT-IA. It is desirable to specify hearing loss criteria toward frequencies vital for speech perception, and to refine grading scales to reveal subtle and clinically relevant dissimilarities in ototoxicity between different treatment protocols.

Sign in / Sign up

Export Citation Format

Share Document