Nimotuzumab-cisplatin-radiation versus cisplatin-radiation in HPV negative oropharyngeal cancer

BACKGROUND: Addition of nimotuzumab to weekly cisplatin and radiation improves outcomes in head and neck cancer. HPV negative oropharyngeal cancer has unsatisfactory treatment outcomes and is a candidate for escalation of treatment. We wanted to determine whether the addition of nimotuzumab to cisplatin-radiation could improve outcomes in these poor-risk tumors.METHODS: This was a subgroup analysis of a phase 3 randomized study. In this study, locally advanced head and neck cancer patients undergoing definitive chemoradiation were randomly allocated to weekly cisplatin (30 mg/m2 IV)- radiation (66–70 Gy) {CRT arm} or nimotuzumab (200 mg weekly) -weekly cisplatin (30 mg/m2)-radiation (66–70 Gy) {NCRT arm}. The data of HPV negative oropharyngeal cancer was extracted from the database of this study for the analysis. HPV testing was done with p16 immunohistochemistry (IHC) staining and reported according to the CAP criteria. The outcomes assessed were progression-free survival (PFS), disease-free survival (DFS), locoregional control, and overall survival (OS). Interaction test was performed between the study arms and HPV status prior to doing any HPV specific analysis for each of the studied outcomes. Kaplan Meier estimates for 2 year OS with 95% CI was calculated. The hazard ratio was obtained using COX regression analysis.RESULTS: We had 187 HPV negative oropharyngeal cancers, 91 in the CRT arm and 96 in NCRT arm. The interaction test was significant for PFS (p = 0.000), locoregional control (p = 0.007) and overall survival (p = 0.002) but not for DFS (p = 0.072). The 2- year PFS was 31.5% (95%CI 21.5–42) in CRT arm versus 57.2% (95%CI 45.8–67.1) in NCRT arm (HR -0.54; 95%CI 0.36–0.79, p = 0.002). The 2-year LRC was 41.4% (95%CI 29.8–52.6) in the CRT arm versus in 60.4% (95%CI 48.7–70.2) in the NCRT arm (HR -0.61; 95%CI 0.4–0.94, p = 0.024). The addition of nimotuzumab also lead to an improvement in 2-year OS from 39.0% (95%CI 28.4–49.6) to 57.6% (95%CI 46.3–67.4) (HR-0.63, 95%CI 0.43–0.92, p = 0.018).CONCLUSIONS: The addition of nimotuzumab to weekly cisplatin-radiation improves outcomes inclusive of OS in HPV negative oropharyngeal cancers.<br/

Nimotuzumab-cisplatin-radiation versus cisplatin-radiation in HPV negative oropharyngeal cancer

BACKGROUND: Addition of nimotuzumab to weekly cisplatin and radiation improves outcomes in head and neck cancer. HPV negative oropharyngeal cancer has unsatisfactory treatment outcomes and is a candidate for escalation of treatment. We wanted to determine whether the addition of nimotuzumab to cisplatin-radiation could improve outcomes in these poor-risk tumors.METHODS: This was a subgroup analysis of a phase 3 randomized study. In this study, locally advanced head and neck cancer patients undergoing definitive chemoradiation were randomly allocated to weekly cisplatin (30 mg/m2 IV)- radiation (66–70 Gy) {CRT arm} or nimotuzumab (200 mg weekly) -weekly cisplatin (30 mg/m2)-radiation (66–70 Gy) {NCRT arm}. The data of HPV negative oropharyngeal cancer was extracted from the database of this study for the analysis. HPV testing was done with p16 immunohistochemistry (IHC) staining and reported according to the CAP criteria. The outcomes assessed were progression-free survival (PFS), disease-free survival (DFS), locoregional control, and overall survival (OS). Interaction test was performed between the study arms and HPV status prior to doing any HPV specific analysis for each of the studied outcomes. Kaplan Meier estimates for 2 year OS with 95% CI was calculated. The hazard ratio was obtained using COX regression analysis.RESULTS: We had 187 HPV negative oropharyngeal cancers, 91 in the CRT arm and 96 in NCRT arm. The interaction test was significant for PFS (p = 0.000), locoregional control (p = 0.007) and overall survival (p = 0.002) but not for DFS (p = 0.072). The 2- year PFS was 31.5% (95%CI 21.5–42) in CRT arm versus 57.2% (95%CI 45.8–67.1) in NCRT arm (HR -0.54; 95%CI 0.36–0.79, p = 0.002). The 2-year LRC was 41.4% (95%CI 29.8–52.6) in the CRT arm versus in 60.4% (95%CI 48.7–70.2) in the NCRT arm (HR -0.61; 95%CI 0.4–0.94, p = 0.024). The addition of nimotuzumab also lead to an improvement in 2-year OS from 39.0% (95%CI 28.4–49.6) to 57.6% (95%CI 46.3–67.4) (HR-0.63, 95%CI 0.43–0.92, p = 0.018).CONCLUSIONS: The addition of nimotuzumab to weekly cisplatin-radiation improves outcomes inclusive of OS in HPV negative oropharyngeal cancers.<br/

Checkpoint inhibitor accessibility in 15,000+ Indian patients

Background: Access to newer therapies is an issue in low and low middle income countries. Hence we decided to audit our practice in the head and neck and thoracic medical oncology unit from 2015to 2019 to study the accessibility of check point inhibitors and factors influencing them.Methods: All patients who were registered in the head and neck and thoracic medical oncology unit between 2015 -2019 were included in the study. The number of patients who received immunotherapy among them was identified from the prospective database of immunotherapy maintained in the department. We made a list of patients who were eligible for immunotherapy per year and identified how many of them received recommended immunotherapy. The indication for eligibility of immunotherapy was based on published pivotal data and its date of publication of the study online. For nominal and ordinal variable percentage with 95% CI was provided. Factors impacting the accessibility of immunotherapy were identified.Results: A total of15,674 patients were identified who required immunotherapy; out of them only 444 (2.83%, 95% CI, 2.58.1) received it. The distribution of patients eligible as per cancer disease management group and time period is shown in the Table. Among head and neck cancer patients 4.5% (156 out of 3,435) received immunotherapy versus 2.35% (288 out of 12,239) among thoracic cancer patients (p&lt;0.0001). Among the general category (low socioeconomic), 0.29% (28 out of 9,405) versus 6.6% (416 out of 6,269) among the private category (high socioeconomic) received immunotherapy (p&lt;0.0001). While 3.7% (361 out of 9,737) among males versus 1.39% (83 out of 5,937) females received immunotherapy (p&lt;0.0001). There was also a temporal trend seen in the accessibility of immunotherapy (p&lt;0.0001, Table).Conclusions: The accessibility of immunotherapy is below 3% in India. Patients with head and neck cancers, those with private category and with male gender had higher access to this therapy. There was also a temporal trend observed suggesting increased accessibility over the years. <br/

Checkpoint inhibitor accessibility in 15,000+ Indian patients

Background: Access to newer therapies is an issue in low and low middle income countries. Hence we decided to audit our practice in the head and neck and thoracic medical oncology unit from 2015to 2019 to study the accessibility of check point inhibitors and factors influencing them.Methods: All patients who were registered in the head and neck and thoracic medical oncology unit between 2015 -2019 were included in the study. The number of patients who received immunotherapy among them was identified from the prospective database of immunotherapy maintained in the department. We made a list of patients who were eligible for immunotherapy per year and identified how many of them received recommended immunotherapy. The indication for eligibility of immunotherapy was based on published pivotal data and its date of publication of the study online. For nominal and ordinal variable percentage with 95% CI was provided. Factors impacting the accessibility of immunotherapy were identified.Results: A total of15,674 patients were identified who required immunotherapy; out of them only 444 (2.83%, 95% CI, 2.58.1) received it. The distribution of patients eligible as per cancer disease management group and time period is shown in the Table. Among head and neck cancer patients 4.5% (156 out of 3,435) received immunotherapy versus 2.35% (288 out of 12,239) among thoracic cancer patients (p&lt;0.0001). Among the general category (low socioeconomic), 0.29% (28 out of 9,405) versus 6.6% (416 out of 6,269) among the private category (high socioeconomic) received immunotherapy (p&lt;0.0001). While 3.7% (361 out of 9,737) among males versus 1.39% (83 out of 5,937) females received immunotherapy (p&lt;0.0001). There was also a temporal trend seen in the accessibility of immunotherapy (p&lt;0.0001, Table).Conclusions: The accessibility of immunotherapy is below 3% in India. Patients with head and neck cancers, those with private category and with male gender had higher access to this therapy. There was also a temporal trend observed suggesting increased accessibility over the years. <br/