Long-Term Results for MC1273, A Phase II Evaluation of De-Escalated Adjuvant Radiation Therapy for Human Papillomavirus Associated Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC)

Ma, Daniel; Price, Katharine A.; Eric, M.J.; Patel, Samir H.; Hinni, Michael L.; Ginos, Brenda; Fruth, Briant; Foster, Nathan R.; Chintakuntlawar, Ashish V.; Neben-Wittich, M.A.; Garces, Yolanda I.; Abel, K. Van; Price, Daniel L.; Kasperbauer, Jan L.; Janus, Jeffrey R.; Nagel, Thomas H.; García, Joaquín J.; Foote, Robert L.

doi:10.1016/j.ijrobp.2021.07.155

Cited by 9 publications

(16 citation statements)

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“…Some have advocated that patients who smoke have worse prognoses even with HPV-mediated disease and, because of this concern, some treatment de-escalation trials exclude those with a significant smoking history. 19,21,24 In our study, limiting assessment of contralateral recurrences to ever-smokers still resulted in a low contralateral nodal recurrence rate. We are wary of attributing risk of contralateral recurrence solely to smoking in part due to the heterogeneity of patient demographics and treatment approaches in our overall cohort.…”

Section: Discussionmentioning

confidence: 60%

Long-term Locoregional Control With Unilateral Radiation for AJCC-7 T1-2N2b Tonsillar Cancer

Frankart

Abana

Geier

et al. 2022

American Journal of Clinical Oncology

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Objectives: Unilateral radiation to cervical nodes has been used as a deescalation strategy in well-lateralized tonsil cancers. The efficacy of this approach with multiple ipsilateral nodes is not established. The study hypothesis was that unilateral radiation for American Joint Committee on Cancer (AJCC)-7 T1-2N2b tonsillar cancer results in a low rate of contralateral nodal failure. Materials and Methods:This study was a retrospective chart review of patients with AJCC-7 T1-2N2b tonsillar cancer from 2 academic institutions who were treated with unilateral radiation. The primary endpoint was the contralateral nodal failure rate. Locoregional control, overall survival, and the need for gastrostomy tube placement were additional endpoints. Results:The study cohort included 66 patients treated between 2005 and 2016. The median follow-up time was 80.9 months; contralateral nodal failure occurred in 2/66 (3.0%) patients at 4.1 and 20.9 months, respectively. Both patients underwent salvage treatment with long-term subsequent survival. Overall locoregional control at both 2 and 5 years was 93.9% and the median duration of control was not reached. Overall survival at 5 years was 92.4%. Conclusions:The use of unilateral radiation for AJCC-7 T1-2N2b tonsillar cancer resulted in low rates of contralateral nodal failure. This outcome demonstrates the safety of considering unilateral radiation treatment in patients with a relatively high ipsilateral nodal burden.

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Section: Discussionmentioning

confidence: 60%

Long-term Locoregional Control With Unilateral Radiation for AJCC-7 T1-2N2b Tonsillar Cancer

Frankart

Abana

Geier

et al. 2022

American Journal of Clinical Oncology

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“…30 ROC, MC1273 and MC1675 are trials that used the most drastic reduction of radiation doses for definitive and adjuvant RT and reported promising PFS rates. 38,43,45) These trials reduced radiation doses down to the order of 30 Gy delivered over 2 weeks for selected HPV-positive OPC. The literature is abundant to support dose-response relationship between radiation dose to swallowing structures and treatment-related dysphagia.…”

Section: Discussionmentioning

confidence: 99%

“…evaluated the efficacy of 30 to 36 Gy adjuvant RT in TORS-resected, HPV-positive OPC with negative resection margin. [42][43][44][45] MC1273 is a single-arm phase 2 trial with 2 cohorts. 42) Patients with intermediate risks received 30 Gy twice-daily RT with weekly 15 mg/m 2 docetaxel.…”

Section: Roc Trial Boldly Attempted To Reduce Rt Dose To 30mentioning

confidence: 99%

“…Long-term results showed that 5-yr LRC of 100% and 84.1% for both cohorts. 43) Given the favorable outcomes, subsequent MC1675 is a phase 3 trial randomizing margin-negative, HPV-positive OPC after TORS to deintensified 30-36 Gy RT with docetaxel from MC1273 versus the SOC 60 Gy RT with risk-directed week-ly 40 mg/m2 cisplatin. 45) Two-yr PFS were 86.5% versus 95.1% for 30-36 Gy RT and 60 Gy RT, respectively.…”

Section: Roc Trial Boldly Attempted To Reduce Rt Dose To 30mentioning

confidence: 99%

“…44) Data from E3311, MC1273 and MC1675, deintensified adjuvant RT apparently results in 2-yr PFS in the order of 90%. 41,43,45) However, one should note different indications for concurrent adjuvant chemotherapy among trials. Despite promising outcomes from phase 2 trials, a paucity of level 1 evidence and heterogeneous adjuvant regiments still warrant well-designed future trials for optimal deintensification of adjuvant RT.…”

Section: Roc Trial Boldly Attempted To Reduce Rt Dose To 30mentioning

confidence: 99%

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Treatment Deintensification for Human Papillomavirus-Associated Oropharyngeal Cancer: Focused Review of Published Data

Kim¹

2022

Korean J Head Neck Oncol

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Human papillomavirus (HPV) is a causative agent for a subset of oropharyngeal cancer (OPC). The current standard of care (SOC) for locally advanced OPC is 70 Gy definitive radiotherapy (RT) concurrent with cisplatin, which entails significant proportions of acute and late grade 3 or higher toxicities. Accordingly, discovery of favorable prognosis of HPV-related OPC has led to enthusiasm to attenuate subspecialties therapy in multidisciplinary treatment. Diverse deintensification strategies were investigated in multiple phase 2 trials with an assumption that attenuated treatments result in comparable oncologic outcome and less toxicities compared with SOC. Several trials on chemotherapy deintensification revealed that concomitant administration of cisplatin is not to be omitted or substituted for cetuximab without compromising progression-free survival or local control. A transoral robotic surgery (TORS) is investigated as alternative local treatment, but TORS plus SOC or mild deintensified adjuvant RT showed similar toxicities and inferior oncologic outcomes compared with SOC definitive RT or moderately deintensified RT. However, it has been reported that TORS plus deintensified 30-36 Gy adjuvant RT results in excellent outcome and less late toxicity compared with SOC adjuvant RT. Several phase 2 trials reported apparently equivalent progression-free survival and local control and similar adverse effects with moderately deintensified 60 Gy RT compared with SOC 70 Gy RT. Further dose reduction below 60 Gy has been investigated using biology-directed approaches, which use response to induction chemotherapy or metabolic images to triage HPV-positive OPC for deintensified RT. In summary, these trials provide valuable insights for future directions. Available evidence consistently showed that moderately deintensified RT is effective and safe for HPV-positive OPC in both definitive and adjuvant settings. Concurrent cisplatin remains an essential component without which progression-free survival is significantly compromised for advanced HPV-positive OPC. A simple incorporation of TORS to SOC may be detrimental for oncologic outcome without anticipated toxicity reduction. Given the lack of level 1 evidence, it is prudent to curb an unjustified deviation from the current SOC and limit any deintensified strategies to clinical trials and adhere to the current SOC.

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Advances and Challenges in Treatment De-Intensification of HPV-Associated Oropharyngeal Squamous Cell Carcinoma

Cao

Quon

2022

Curr Otorhinolaryngol Rep

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Long-Term Results for MC1273, A Phase II Evaluation of De-Escalated Adjuvant Radiation Therapy for Human Papillomavirus Associated Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC)

Cited by 9 publications

References 0 publications

Long-term Locoregional Control With Unilateral Radiation for AJCC-7 T1-2N2b Tonsillar Cancer

Long-term Locoregional Control With Unilateral Radiation for AJCC-7 T1-2N2b Tonsillar Cancer

Treatment Deintensification for Human Papillomavirus-Associated Oropharyngeal Cancer: Focused Review of Published Data

Advances and Challenges in Treatment De-Intensification of HPV-Associated Oropharyngeal Squamous Cell Carcinoma

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