Docetaxel plus radiation new standard of care in cisplatin-ineligible head and neck cancer

Source: www.healio.com Author: Devin McLaughlin Perspective author: Marshall Posner, MD Docetaxel prolonged DFS (disease free survival) and OS (overall survival) when added to radiation for cisplatin-ineligible patients with locally advanced head and neck squamous cell carcinoma, according to study results presented at ASCO Annual Meeting. The addition of docetaxel also did not appear to worsen quality of life at 6 months, researchers concluded. “This now represents the new reference standard of care for cisplatin-ineligible patients planned for chemoradiotherapy,” Vanita Noronha, MD, of the department of medical oncology at Tata Memorial Center in Mumbai, India, said during a presentation. Background and methods Docetaxel has shown promise in phase 1 and phase 2 studies among patients unsuitable for cisplatin — a standard therapy in chemoradiation for locally advanced HNSCC, according to Noronha. However, limited prospective data exist in this setting. The open-label, randomized phase 3 study by Noronha and colleagues examined docetaxel as a radiosensitizer among 356 cisplatin-ineligible patients with locally advanced HNSCC set for treatment with radical or adjuvant chemoradiation. Researchers randomly assigned patients to radiation alone (n = 176) or with concurrent docetaxel dosed at 15 mg/m2 weekly for up to seven cycles (n = 180). Patients in the docetaxel group received a median six cycles of the treatment. The radiotherapy-alone and combination therapy groups had similar baseline characteristics, including median age (63 years vs. 61 years), ECOG performance status (59.7% vs. 50.6%) and reasons for cisplatin ineligibility (low creatinine clearance, 26.7% vs. 26.1%; hearing loss, 42.6% vs. 45%; ECOG [...]

Immunotherapy drug a ‘gamechanger’ for head and neck cancer

Source: www.theguardian.com Author: staff An immunotherapy drug hailed as a potential gamechanger in the treatment of cancer could soon offer new hope to patients with currently untreatable forms of the disease. Nivolumab outperformed chemotherapy significantly in keeping relapsed head and neck cancer patients alive. Photograph: Alamy Nivolumab was found to extend the lives of relapsed patients diagnosed with head and neck cancers who had run out of therapy options. After a year of treatment, 36% of trial patients treated with the drug were still alive compared with 17% of those given standard chemotherapy. Trial participants treated with nivolumab typically survived for 7.5 months, and some for longer. Middle-range survival for patients on chemotherapy was 5.1 months. The phase-three study, the last stage in the testing process before a new treatment is licensed, provided the first evidence of a drug improving survival in this group of patients. Prof Kevin Harrington, from the Institute of Cancer Research, London, who led the British arm of the international trial, said: “Nivolumab could be a real gamechanger for patients with advanced head and neck cancer. This trial found that it can greatly extend life among a group of patients who have no existing treatment options, without worsening quality of life. “Once it has relapsed or spread, head and neck cancer is extremely difficult to treat. So it’s great news that these results indicate we now have a new treatment that can significantly extend life, and I’m keen to see it enter the clinic [...]

Expert says Nivolumab Poised to Change Standard of Care in SCCHN

Source: www.onclive.com Author: Laura Panjwani Nivolumab (Opdivo) is a game-changing agent for the treatment of patients with squamous cell carcinoma of the head and neck (SCCHN), according to Robert L. Ferris, MD, PhD. “Recent findings have shown us that this agent is really the new standard-of-care option for all platinum-refractory patients with head and neck cancer,” says Ferris, vice chair for Clinical Operations, associate director for Translational Research, and co-leader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute. “This is regardless of whether patients are PD-L1–positive or negative or whether they are HPV-positive or negative.” The PD-L1 inhibitor received a priority review designation by the FDA in July 2016 based on the CheckMate-141 study, which demonstrated a median overall survival (OS) with nivolumab of 7.5 months compared with 5.1 months with investigator's choice of therapy (HR, 0.70; 95% CI, 0.51-0.96; P = .0101) in patients with recurrent or metastatic SCCHN. The objective response rate (ORR) was 13.3% with nivolumab and 5.8% for investigator's choice. The FDA is scheduled to make a decision on the application for the PD-1 inhibitor by November 11, 2016, as part of the Prescription Drug User Fee Act. Ferris was the lead author on an analysis that further evaluated preliminary data from CheckMate-141, which was presented at the 2016 ASCO Annual Meeting. In an interview with OncLive, he discusses the findings of this study, potential biomarkers for nivolumab, and questions that remain regarding the use of the immunotherapy in SCCHN. OncLive: What [...]

2016-08-24T13:28:58-07:00August, 2016|Oral Cancer News|

Nivolumab Improved Survival For Patients With Head and Neck Squamous Cell Carcinoma

Source: www.aacr.orgAuthor: AACR Newsroom Staff NEW ORLEANS — Treatment with the immunotherapeutic nivolumab (Opdivo) improved survival for patients with recurrent or metastatic head and neck squamous cell carcinoma that progressed after platinum-based chemotherapy compared with single-agent chemotherapy of the investigator’s choice, according to results from the CheckMate-141 phase III clinical trial presented here at the AACR Annual Meeting 2016, April 16-20. “Recurrent or metastatic head and neck squamous cell carcinoma that is not responsive to platinum-based chemotherapy progresses very rapidly, and patients have a very poor prognosis,” said Maura L. Gillison, MD, PhD, a professor in the Department of Internal Medicine at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. “Treatment usually involves single-agent chemotherapy. However, no therapy has been shown to improve survival for this patient population. New treatment options are desperately needed. “This study is the first randomized clinical trial to clearly demonstrate improved overall survival for patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma,” continued Gillison. “We hope that the results will establish nivolumab as a new standard of care option for this patient population and thereby fulfill a huge unmet need.” CheckMate-141 was a randomized, phase III clinical trial designed to determine whether the PD-1 inhibitor nivolumab could extend overall survival for patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma compared with treatment of the investigator’s choice, which was any of the commonly used therapeutics docetaxel, methotrexate, or [...]

2016-04-19T10:49:39-07:00April, 2016|OCF In The News, Oral Cancer News|

Immunotherapies gaining traction in head and neck cancers

Source: www.targetedonc.com Author: Greg Kennelty An explosion of immunotherapies is on the horizon for patients with metastatic head and neck cancer, specifically as phase III trials begin to report findings for PD-1 inhibitors. This upcoming wave of new therapies places importance on understanding optimal treatment settings and adverse events associated with these therapies. In late January, the phase III CheckMate-141 trial investigating the anti–PD-1 agent nivolumab was stopped early, due to a substantial improvement in the primary endpoint of overall survival (OS). The drug was put up against the investigator’s choice of cetuximab (Erbitux), methotrexate, or docetaxel following progression on a platinum-based therapy. At this time, data from the study have not yet been released but are being prepared for future presentation. Findings from the study are being discussed with the FDA and other health authorities. In addition to nivolumab, the PD-1 inhibitor pembrolizumab (Keytruda) demonstrated encouraging activity in patients with with advanced PD-L1–positive esophageal carcinoma during the phase Ib KEYNOTE-028 study. Additionally, the agent was effective for patients with squamous cell carcinoma of the head and neck in the phase I KEYNOTE-012 study. In the head and neck cancer population, the objective response rate with pembrolizumab was 24.8% in 117 evaluable patients. Tumor shrinkage was experienced by 56% of patients and another 25% had stable disease. The response rate seen with pembrolizumab was similar, regardless of HPV infection status. In those with HPV-positive disease, the ORR was 20.6% compared with 27.2% in the negative group. To gain further insight, [...]

2016-02-18T14:35:44-07:00February, 2016|Oral Cancer News|

Nivolumab Could Change Head and Neck Cancer Treatment Paradigm

Source: www.Targetedonc.comAuthor: Laura Panjwani "To have an anti–PD-1 agent be proven to improve survival in head and neck cancer in a randomized phase III trial, and the potential for a new FDA approval in the near future is a game changer." - Robert Ferris, MD, PhD With the phase III CheckMate-141 trial being stopped early due to the anti–PD-1 agent nivolumab having met its primary endpoint of overall survival improvement in head and neck cancer, Robert Ferris, MD, PhD, couldn't be more elated. "This is what I've devoted my career to, and it is gratifying to see that really come to pass," said Ferris, professor and chief, Division of Head and Neck Surgery, vice chair for Clinical Operations, associate director for Translational Research, and coleader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute, in an exclusive interview with Targeted Oncology. "To have an anti–PD-1 agent be proven to improve survival in head and neck cancer in a randomized phase III trial, and the potential for a new FDA approval in the near future is a game changer. There is now hope for a lot of patients and physicians who have been frustrated by this difficult-to-treat disease. This opens up a whole new class of therapies for this population." Ferris, who acted as cochair/coprimary investigator for the trial alongside Maura Gillison, MD, PhD, Ohio State University, said the trial pitted nivolumab against the investigator’s choice of cetuximab (Erbitux), methotrexate, or docetaxel in patients with platinum-refractory squamous cell carcinoma [...]

2016-02-16T09:24:23-07:00February, 2016|Oral Cancer News|

Docetaxel regimen tops cisplatin in head and neck cancer

Source: www.cancernetwork.com Author: Anna Azvolinsky, PhD A phase II study has demonstrated that combining docetaxel-based chemoradiotherapy and the antibody cetuximab postoperatively in patients with high-risk squamous cell carcinoma of the head and neck led to improved disease-free and overall survival, with no unexpected toxicities. The results of the study were published in the Journal of Clinical Oncology. Two-hundred and thirty-eight stage III and IV patients were randomized to receive radiation therapy (60 Gy) plus cetuximab and either cisplatin (30 mg/m2) or docetaxel (15 mg/m2) once per week as part of the Radiation Therapy Oncology Group (RTOG) 0234 clinical trial. The 2-year overall survival (OS) was 69% in the cisplatin treatment arm and 79% in the docetaxel treatment arm. The 2-year disease-free survival (DFS) was 57% and 66% in the cisplatin and docetaxel arms, respectively. Previously, two large phase III trials, the RTOG 9501 and the European Organisation for Research and Treatment of Cancer (EORTC) 22931 trials, both showed a small but significant survival benefit for postoperative head and neck cancer patients who received adjuvant radiation and chemotherapy concurrently, resulting in the incorporation of cisplatin in an adjuvant regimen for high-risk patients. The drawback was that adding cisplatin to radiation therapy increased toxicity. Many of these patients are not candidates for the combination therapy due to poor performance status, older age, and renal insufficiency. The purpose of the current trial was to test whether combining a molecular therapy such as cetuximab with chemotherapy would improve survival with a better toxicity profile, [...]

Neoadjuvant chemo does not improve oral cancer survival rates

Source: www.drbicuspid.com Author: DrBicuspid Staff Patients with advanced resectable oral squamous cell carcinoma (OSCC) who undergo surgery do not benefit from improved survival after induction with docetaxel, cisplatin, and fluorouracil (TPF), according to a new study (Journal of Clinical Oncology, November 5, 2012). Study author Zhi-yuan Zhang, MD, PhD, from Shanghai Jiao Tong University School of Medicine, and colleagues assessed 256 patients with resectable locally advanced OSCC. A total of 222 patients completed the full treatment protocol. They received two cycles of TPF induction chemotherapy (75 mg/m2 of docetaxel on day 1, 75 mg/m2 of cisplatin on day 1, and 750 mg/m2 of fluorouracil on days 1 to 5) followed by radical surgery and postoperative radiotherapy versus upfront radical surgery and postoperative radiotherapy. The primary end point was overall survival. Secondary end points included local control and safety. After a median follow-up of 30 months, there was no significant difference in overall survival or disease-free survival between patients treated with or without TPF induction, the study authors noted. Patients in the induction chemotherapy arm with a clinical response or favorable pathologic response had superior overall survival and locoregional and distant control. "Our study failed to demonstrate that TPF induction chemotherapy improves survival compared with upfront surgery in patients with resectable stage III or IVA OSCC," the authors concluded. The lack of survival benefit indicates that TPF induction chemotherapy without selection could not benefit OSCC patients in general, Dr. Zhang told Reuters Health in a news story. "On the other hand, [...]

2012-11-11T19:34:34-07:00November, 2012|Oral Cancer News|

Facing the facts: HPV-associated head and neck cancers get a second look

Source: www.curetoday.com Author: Charlotte Huff Kevin Pruyne knew he didn’t fit the stereotype of a hard drinker or heavy smoker who one day develops an oral cancer. The 52-year-old mechanic had been working a three-week stint in a remote section of northern Alaska, repairing trucks on an oil field, when he noticed a hard lump beneath his jaw while shaving. For nearly three months, as Pruyne was prescribed antibiotics for a possible infection and then later shuttled between physician specialists, he kept hearing the same thing: the lump could not be cancer. Pruyne only occasionally consumed alcohol and had never smoked. His wife, Kathy, began researching her husband’s symptoms, which included repetitive throat clearing, a nagging sensation that something was lodged in his throat and ringing in his ears. And the lump, which looked like the top half of an egg, felt solid to the touch. This wasn’t some inflamed lymph node from a lingering head cold, Kathy Pruyne says. “He had every symptom [of cancer], but nobody would listen to me.” Pruyne received a diagnosis of stage 4 oral cancer, which started with a tumor at the base of his tongue. He had already begun chemotherapy when he learned that researchers had discovered an association between the human papillomavirus (HPV) and increasing rates of oropharyngeal cancers. He asked that his tissue be tested; the results came back positive. Pruyne says he wanted to know whether his cancer was caused by HPV because “the prognosis is considerably better with HPV-positive cancer.” [...]

Larynx preservation studies should consider treatment impact

Source: www.internalmedicinenews.com Author: Sara Freeman, Internal Medicine News Digital Network Almost one-quarter of patients who had been given induction chemotherapy before radiotherapy for head and neck cancer experienced long-term swallowing difficulties, with another 15% experiencing voice disabilities that correlated with the mobility of the vocal cords. Long-term data from the GORTEC (Groupe Oncologie Radiothérapie Tête et Cou) 2000-01 larynx preservation trial also show that approximately two-thirds of long-term head and neck cancer survivors experienced severe problems with sticky saliva and dry mouth, which were in turn linked to nutritional problems. These findings, reported May 9 at the European Society for Therapeutic Radiation Oncology (ESTRO) Anniversary Conference, further confirm that studies looking at the effects of chemoradiotherapy on the larynx in head and neck cancer need to consider prospective assessment of laryngeal function, rather than just looking at anatomical preservation, according to a French radiation oncologist. Dr. Gilles Calais of the Centre Hôpitalier Régional et Universitaire de Tours (France) presented data from a prospective analysis of 61 patients who had participated in the original 213-patient GORTEC 2000-01 trial. He also presented updated results from the trial using a recently developed composite end point. "Larynx preservation can be achieved for most of our [head and neck] patients by using three different strategies: induction chemotherapy, concomitant [chemoradiotherapy], or alternating chemoradiotherapy," Dr. Calais observed. Indeed, larynx preservation is a possibility in approximately 80% of patients, he said. However, anatomical preservation does not mean that laryngeal function is maintained, especially with respect to the ability [...]

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