7 juni 2021: ASCO 2021

Hier een aantal aanbevolen abstracten over studies bij mond- en keelkanker door artsen die werken voor ASCO zelf. Deze aanbevelingen doet Barbara Burtness MDProfessor of Medicine (Medical Oncology); Disease Aligned Research Team Leader, Head and Neck Cancers Program; Co-Leader, Developmental Therapeutics, Yale Cancer Center.

Klik op de nummers van de abstracten:

Oral Abstract Session: Head and Neck Cancer 
Monday, June 7, 2021; 2:45 PM– 5:45 PM EDT

6000 Camrelizumab versus placebo combined with gemcitabine and cisplatin for recurrent or metastatic nasopharyngeal carcinoma: A randomized, double-blind, phase 3 trial. L Zhang, Y Yang, S Qu, et al

Take-Home Message

  • Patients with previously untreated recurrent or metastatic nasopharyngeal carcinoma were given either camrelizumab or placebo with gemcitabine and cisplatin (GB) chemotherapy to assess the efficacy and safety profile. An independent review committee found that the PFS was 10.8 months (95% CI, 8.5–13.6) with camrelizumab and 6.9 (95% CI, 5.9–7.9) with placebo (HR, 0.51; 95% CI, 0.37–0.69; one-sided P < .0001). Grade ≥3 treatment-associated adverse events occurred at similar rates in both arms, 93% for camrelizumab and 90% for placebo.
  • Camrelizumab plus GB as a first-line therapy was well-tolerated by patients and significantly increased PFS.  

6001 Cabozantinib versus placebo in patients with radioiodine-refractory differentiated thyroid cancer who have progressed after prior VEGFR-targeted therapy: Results from the phase 3 COSMIC-311 trial. MS Brose, B Robinson, SI Sherman, et al

Take-Home Message

  • Patients with radioiodine-refractory thyroid cancer who had prior treatment with VEGFR inhibitors were given either cabozantinib or placebo to assess efficacy and safety. At the 6-month follow-up, a blinded independent radiology committee determined that there was a significant improvement in the PFS of patients given cabozantinib (HR, 0.22; 96% CI, 0.13–0.36; P < .0001). The ORR and OS trends were also positive. There were more grade 3/4 treatment-associated adverse events in the cabozantinib group (57%) than in the placebo group (26%).
  • Cabozantinib was associated with a significant improvement in PFS for patients with previously treated radioiodine-refractory thyroid cancer, for whom there is no current standard of care. The treatment was well-tolerated with manageable toxicity.

6002 A phase II trial cohort of nivolumab plus ipilimumab in patients (Pts) with recurrent/metastatic salivary gland cancers (R/M SGCs). B Burman, EJ Sherman, L Dunn, et al

Take-Home Message

  • The objective of this phase II trial was to evaluate whether the combination of nivolumab plus ipilimumab was effective in treating patients with recurrent/metastatic salivary gland cancers. The best overall response rate was 16% (5/32 patients), which met the target for the primary endpoint (at least 4/32 patients). The target (an observed response in 1 of the first 18 patients) to move forward with enrollment for the second stage was also met (3/18 patients). Toxicity was reported for 5 patients, who discontinued the trial. The 5 confirmed responders had observed reductions in the target lesions ranging from −66% to −100%.
  • There were positive and durable responses to the nivolumab plus ipilimumab combination, and the primary endpoint was met.

6006 Association of pathological response to neoadjuvant pembrolizumab with tumor PD-L1 expression and high disease-free survival (DFS) in patients with resectable, local-regionally advanced, head and neck squamous cell carcinoma (HNSCC). TM Wise-Draper, V Takiar, ML Mierzwa, et al

Take-Home Message

  • Patients with high- or intermediate-risk resectable HNSCCs were given pembrolizumab before surgery followed by radiation with adjuvant pembrolizumab with (high-risk) or without (intermediate-risk) cisplatin. At the median follow-up of 20 months, the primary endpoint of 1-year DFS for the high-risk group was 67% (95% CI, 0.52–0.85) and 93% (95% CI, 0.84–1) for the intermediate-risk group. Pathological response was observed in 32/80 patients and was significantly associated with an improved 1-year DFS (P = .01; HR, 0.23) and with PD-L1 expression (P = .0007). The rate of grade ≥3 treatment-related adverse events was 62%.
  • Neoadjuvant pembrolizumab significantly improved the 1-year DFS for PD-L1+ patients and was well-tolerated.

6007 Primary results of the phase II CheckRad-CD8 trial: First-line treatment of locally advanced head and neck squamous cell carcinoma (HNSCC) with double checkpoint blockade and radiotherapy dependent on intratumoral CD8+ T-cell infiltration. M Hecht, M Eckstein, S Rutzner, et al

Take-Home Message

  • Patients with previously untreated locally advanced HNSCCs were given one dose of chemotherapy (cisplatin and docetaxel) and combined PD-L1/CTLA-4 inhibitors (durvalumab and tremelimumab). Those who had a pathological complete response or at least a 20% increase of CD8+ T-cell density in the re-biopsy entered radio-immunotherapy. The calculated sample size (57 patients) to enter RIT was met (60 patients), and the feasibility rate until cycle 6 was 82%, meeting the primary endpoint. The overall PFS rate was 75% (CI, 65%–85%) and 68% (CI, 58%–81%) at the 1-year and 2-year follow-up, respectively. The OS rate was 86% (CI, 78%–95%) and 80% (CI, 70%–91%) at the 1-year and 2-year follow-up, respectively. The overall rate of grade ≥3 adverse events was 95%.
  • CD8+ T-cell density–dependent radio-immunotherapy with double checkpoint blockade demonstrated promising PFS rates for patients with advanced HNSCCs.

Poster Discussion Session: Head and Neck Cancer
Available Starting on Friday, June 4, 2021; 9:00 EDT

6010 Updated report of a phase II randomized trial of transoral surgical resection followed by low-dose or standard postoperative therapy in resectable p16+ locally advanced oropharynx cancer: A trial of the ECOG-ACRIN cancer research group (E3311). RL Ferris, Y Flamand, GS Weinstein, et al

Take-Home Message

  • This study presents the 3-year PFS rates and patient-reported outcomes (PRO) including quality of life (QOL) measures. Patients were divided into four groups (one group no postoperative RT , two groups reduced-dose PORT, one group regular-dose PORT plus cisplatin). The 3-year PFS rates of patients in the reduced-dose PORT groups were higher (94.9% for the 50-Gy group and 93.5% for the 60-Gy group) than the rate of the chemoradiation group (90.7%; 66 Gy). Reduced-dose PORT was associated with a higher proportion of patients with stable or improved head and neck cancer–specific QOL (56% vs 38%; P = .011, one-sided Fisher’s exact test). Of the two reduced-dose PORT groups, lower doses of RT were associated with improved QOL (63% vs 49%; P = .056).
  • The 35-month follow-up confirmed that reduced-dose PORT following primary transoral surgery is effective for the treatment of patients with intermediate risk HPV+ oropharynx cancer and is associated with a better QOL profile than the standard of care.

6011 Nivolumab, nabpaclitaxel, and carboplatin followed by risk/response adaptive de-escalated locoregional therapy for HPV-associated oropharyngeal cancer: OPTIMA II trial. A Rosenberg, N Agrawal, AT Pearson, et al

Take-Home Message

  • The effectiveness of risk-based treatment de-escalation was tested in patients with locoregionally advanced HPV+ oropharyngeal cancer (OPC). At the median follow-up of 23.1 months, the deep response rate (DDR; ≥50% shrinkage from induction therapy) was 70.8% (95% CI, 60.3%–81.3%). The PFS and OS rates were comparable between the two treatment de-escalation arms and the standard-of-care arm. Treatment de-escalation was associated with lower rates of enteral feeding and grade 4 toxicity.
  • Risk-based treatment de-escalation following induction with nivolumab, nab-paclitaxel, and carboplatin is associated with excellent PFS and OS rates as well as reduced toxicity for patients with HPV+ OPC, including high-risk patients.

6012 Randomized trial of radiotherapy with weekly cisplatin or cetuximab in low risk HPV associated oropharyngeal cancer (TROG 12.01): A Trans-Tasman Radiation Oncology Group study. D Rischin, MT King, LM Kenny, et al

Take-Home Message

  • The goal of this study was to evaluate whether cetuximab following radiotherapy would be associated with a better toxicity profile than cisplatin while maintaining efficacy for patients with low-risk HPV-associated oropharyngeal cancer. There was no difference in symptom severity or in the mean number of grade >3 adverse events (82 vs 4.35; P = .108). Additionally, cetuximab was also associated with a lower 3-year failure-free survival rate (80% vs 93%; HR, 3.0; 95% CI, 1.2–7.7; P = .015).
  • Radiotherapy and cetuximab was associated with a higher failure rate and a similar toxicity profile compared with the standard of care and should not be adopted.

6015 Randomized phase II trial of ficlatuzumab with or without cetuximab in pan-refractory, advanced head and neck squamous cell carcinoma (HNSCC). JE Bauman, NF Saba, D Roe, et al

Take-Home Message

  • This study assessed the efficacy ficlatuzumab alone or in combination with cetuximab for the treatment of pan-refractory, advanced HNSCC. Ficlatuzumab alone was stopped for futility. Ficlatuzumab in combination with cetuximab was associated with a median PFS of 3.6 months and an ORR of 19%; all of the responses were in HPV-negative In the HPV-negative patient population, the median PFS was 3.8 months and the ORR was 38%.
  • The ficlatuzumab and cetuximab combination was well-tolerated and demonstrated a benefit in PFS for patients with pan-refractory, advanced HNSCC.

6019 The 30 ROC trial: Precision intra-treatment imaging guiding major radiation reduction in human papillomavirus related oropharyngeal cancer. NY Lee, EJ Sherman, H Schöder, et al

Take-Home Message

  • This study compared the effects of de-escalation of radiotherapy to 30 Gy plus two cycles of chemotherapy based on absence of tumor hypoxia pre-radiation or resolution of hypoxia 2 weeks into radiotherapy with the standard of care (70 Gy) for patients with HPV-positive oropharyngeal carcinoma. Of the 158 patients enrolled, 24 had persistent hypoxia and 6 withdrew. Of the 128 patients who received the de-escalated radiation dose, only 6 had grade 3 adverse events and none required PEG tubes. Additionally, there were no failures in the primary site, and the 1-year OS, distant metastasis–free survival, and locoregional control rates were 100%, 100%, and 94%, respectively.
  • De-escalation of the radiotherapy dose to 30 Gy based on hypoxia results was associated with excellent response rates and reduced toxicity.

Poster Session: Head and Neck Cancer
Available Starting on Friday, June 4, 2021; 9:00 EDT

6024 Afatinib and pembrolizumab for recurrent or metastatic head and neck squamous cell carcinoma (ALPHA Study): A phase II study with biomarker analysis. H-f Kao, B-C Liao, Y-L Huang, et al

Take-Home Message

  • This study evaluated whether adding afatinib to pembrolizumab would improve outcomes in patients with recurrent or metastatic Of the 29 patients enrolled, 12 had a partial response to the treatment (ORR, 41.4%). The median PFS was 4.1 months (95% CI, 1.9–6.3), and the median OS was 8.4 months (95% CI, 4.1–10.8). Patients with high PD-L1 expression and EGFR amplification had a higher response rate, while MTAP mutation or loss was associated with poorer outcomes.
  • The addition of afatinib to pembrolizumab can be beneficial for patients with PD-L1, EGFR, and MTAP are potential biomarkers.

6038 Use of cetuximab added to weekly chemotherapy to improve progression-free survival in patients with recurrent metastatic head and neck squamous cell carcinoma after progression on immune checkpoint inhibitors. M Issa, B Klamer, V Karivedu, et al

Take-Home Message

  • Of the 64 patients with recurrent metastatic HNSCC who progressed on immune checkpoint inhibitors and received subsequent systemic therapy, 28 (44%) received cetuximab in addition to weekly chemotherapy. There was no significant difference in the ORR (P = .4) or the OS (HR, 0.84; CI, 0.4–1.8; P = .8) between the two groups. However, the chemotherapy plus cetuximab group had a longer median PFS (HR, 0.52; CI, 0.28–0.98; P = .042).
  • The addition of cetuximab to weekly chemotherapy provides a PFS benefit for patients with recurrent or metastatic HNSCC who progress on immune checkpoint inhibitor therapy.

6045 Evaluation of radiomics as a predictor of tumor hypoxia and response to anti-PD-1 mab treatment (IO) in recurrent/metastatic HNSCC patients (R/M). DP Zandberg, S Zenkin, AK Murat AK, et al

Take-Home Message

  • Lower tumor hypoxia is associated with increased IO efficacy in patients with recurrent or metastatic HNSCC. Radiomic signatures were evaluated from archival FFPE samples, and selected features were used to build a model capable of predicting the response to immunotherapy. The model accurately predicted tumor hypoxia status (sensitivity, specificity, and accuracy of 78%, 83%, and 81%, respectively; P = .0001) and whether a patient would respond to therapy (sensitivity, specificity, and accuracy of 93%, 88%, and 92%, respectively; P = .02).
  • These are promising results for the use of radiomics to predict tumor hypoxia and response to IO in patients with recurrent or metastatic HNSCC.

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