(Thyroid Cancer) Is Pazopanib + Paclitaxel + Radiation Therapy Effective?

On January 18, 2023, Eric J Sherman et al. from Memorial Sloan Kettering Cancer Center published in The Lancet Oncology the Phase 2 NRG/RTOG 0912 trial results evaluating the efficacy and safety of pazopanib plus paclitaxel plus radiation therapy in patients with anaplastic thyroid cancer.

Trial Design

NRG/RTOG 0912 was a double-blind, placebo-controlled Phase 2 trial that randomized anaplastic thyroid cancer patients (N=71) in a 1:1 ratio to:

• Arm A: Paclitaxel (80 mg/m² once weekly) + Pazopanib (400 mg once daily) + IMRT (N=36)
• Arm B: Paclitaxel (80 mg/m² once weekly) + Placebo + IMRT (N=35)

Primary endpoint: Overall survival (OS). Secondary endpoint: Safety.

Efficacy Results

At a median follow-up of 2.9 years:

• Median OS: Pazopanib arm 5.7 months vs. Placebo arm 7.3 months — no significant improvement with pazopanib addition
• 1-year OS rate: Pazopanib arm 37.1% vs. Placebo arm 29.0%

Safety Profile

Grade 3–5 adverse event rates were similar between arms:

• Pazopanib arm: 88.9% (N=32/36)
• Placebo arm: 85.3% (N=29/34)

Most common Grade 3–4 adverse events (Pazopanib vs. Placebo):

• Dysphagia: 36% / 29%
• Radiation dermatitis: 22% / 38%
• ALT elevation: 33% / 0%
• AST elevation: 22% / 0%
• Oral mucositis: 14% / 24%

Serious adverse event rates:

• Pazopanib arm: 44% (N=16)
• Placebo arm: 35% (N=12)
• One treatment-related death confirmed in each arm

Conclusions

Based on the NRG/RTOG 0912 trial results, Eric J Sherman et al. concluded that adding pazopanib to paclitaxel plus radiation therapy did not significantly improve overall survival in anaplastic thyroid cancer, though the safety profile was acceptable.

Source: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00763-X/fulltext

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