Advanced-stage therapy

In the multicenter, randomized, phase II International Advanced Anal Cancer InterAACT trial (NCT02560298), carboplatin (area under the curve 5) and weekly paclitaxel was compared with standard infusional 5-FU and bolus cisplatin in patients with advanced-stage anal cancer.[2]These promising findings have led international investigators to use carboplatin and paclitaxel as a new backbone in trials for patients with advanced-stage disease, as well as a potential partner for use with radiation therapy. Other chemotherapy regimens, such as modified docetaxel, cisplatin, and 5-FU, are under clinical evaluation.[3]

In the multicenter, randomized, phase II International Advanced Anal Cancer InterAACT trial (NCT02560298), carboplatin (area under the curve 5) and weekly paclitaxel was compared with standard infusional 5-FU and bolus cisplatin in patients with advanced-stage anal cancer.[2]These promising findings have led international investigators to use carboplatin and paclitaxel as a new backbone in trials for patients with advanced-stage disease, as well as a potential partner for use with radiation therapy. Other chemotherapy regimens, such as modified docetaxel, cisplatin, and 5-FU, are under clinical evaluation.[3]

With a median follow-up of 25.3 months, the median overall survival (OS) with carboplatin and paclitaxel was improved compared with cisplatin and 5-FU (20 months vs. 12.3 months; hazard ratio [HR], 2.0; P = .014).[Level of evidence A1]

In the multicenter, randomized, phase II International Advanced Anal Cancer InterAACT trial (NCT02560298), carboplatin (area under the curve 5) and weekly paclitaxel was compared with standard infusional 5-FU and bolus cisplatin in patients with advanced-stage anal cancer.[2]These promising findings have led international investigators to use carboplatin and paclitaxel as a new backbone in trials for patients with advanced-stage disease, as well as a potential partner for use with radiation therapy. Other chemotherapy regimens, such as modified docetaxel, cisplatin, and 5-FU, are under clinical evaluation.[3]

Serious adverse events were more common in patients treated with cisplatin plus 5-FU (62% vs. 36%; P = .016).

The checkpoint inhibitors have also shown activity for patients with metastatic disease. The phase II NCI96773 trial (NCT02314169) of single-agent nivolumab (3 mg/kg every 2 weeks) enrolled 37 patients.[4]

The checkpoint inhibitors have also shown activity for patients with metastatic disease. The phase II NCI96773 trial (NCT02314169) of single-agent nivolumab (3 mg/kg every 2 weeks) enrolled 37 patients.[4]

The overall response rate was 24%, including two complete responses.[4][Level of evidence C3]

The phase Ib KEYNOTE-028 trial (NCT02054806) for patients with advanced tumors with programmed death ligand-1 of at least 1% enrolled a cohort of 24 patients with anal squamous cell carcinoma.[5]

The phase Ib KEYNOTE-028 trial (NCT02054806) for patients with advanced tumors with programmed death ligand-1 of at least 1% enrolled a cohort of 24 patients with anal squamous cell carcinoma.[5]

The overall response rate was 17%, and an additional stable disease rate was 42%.[5][Level of evidence C3]