CONTINUUM
CONTINUUM was the first trial to show that adding a PD-1 immunotherapy, sintilimab, to the chemotherapy and radiotherapy given for advanced but not yet metastatic nasopharyngeal cancer keeps more people free of relapse three years later, 86 against 76 percent, at the cost of more side effects.
Overview
CONTINUUM was an open-label randomised phase 3 trial at nine hospitals in China that randomised 425 adults with high-risk locoregionally advanced nasopharyngeal carcinoma to standard gemcitabine-cisplatin induction followed by concurrent cisplatin radiotherapy, with or without sintilimab 200 mg every three weeks for 12 cycles spanning induction, concurrent and adjuvant phases. The primary endpoint was event-free survival.
At a median follow-up of 41.9 months, three-year event-free survival was 86 percent with sintilimab against 76 percent without (hazard ratio 0.59). Grade 3 to 4 adverse events were 74 against 65 percent, grade 3 to 4 immune-related events occurred in 10 percent of the sintilimab group and two immune-related deaths occurred. The corpus's locoregionally advanced nasopharyngeal carcinoma page cites CONTINUUM for adding a PD-1 antibody to chemoradiotherapy, with toripalimab and camrelizumab in parallel trials.
- 86 vs 76 out of 100 free of a major event at 3 years with Sintilimab + induction chemotherapy + concurrent chemoradiotherapy compared with Induction chemotherapy + concurrent chemoradiotherapy; 10 more per 100.
- Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 41 percent lower chance of the event at any given time (hazard ratio 0.59, likely range 0.38 to 0.92).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 74 vs 65 out of 100 reached this endpoint with Sintilimab + chemoradiotherapy compared with Chemoradiotherapy; 9 more per 100.
- On this measure the first group did worse, not better.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- 10 out of 100 people reached this endpoint with Sintilimab + chemoradiotherapy.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: High-risk locoregionally advanced nasopharyngeal carcinoma (stage III to IVa, excluding T3-4N0 and T3N1) in adults aged 18 to 65 at nine Chinese hospitals: gemcitabine-cisplatin induction and concurrent cisplatin radiotherapy with or without 12 cycles of the PD-1 antibody sintilimab, with event-free survival as the primary endpoint. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (PD-1); the result should not be assumed for people whose cancer does not have it.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
425 enrolled.
95% CI 81 to 90; median follow-up 41.9 months · 95% CI 70 to 81
Source20 patients; 2 immune-related deaths
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival at 3 yearsprimary | Sintilimab + induction chemotherapy + concurrent chemoradiotherapy | 210 | 86% | 0.59 (0.38 to 0.92) | 0.019 | link |
| Induction chemotherapy + concurrent chemoradiotherapy | 215 | 76% | ||||
| Grade 3 to 4 adverse events | Sintilimab + chemoradiotherapy | 210 | 74% | - | - | link |
| Chemoradiotherapy | 215 | 65% | ||||
| Grade 3 to 4 immune-related adverse events | Sintilimab + chemoradiotherapy | 210 | 10% | - | - | link |
Similar pages
not linked directly; found by shared links- TrialESPAC-5
Shares Gemcitabine, IMRT / IGRT (modern external beam), Cytotoxic chemotherapy and the tag soc-trials.
- TrialLAP07
Shares Gemcitabine, IMRT / IGRT (modern external beam), Cytotoxic chemotherapy and the tag soc-trials.
- TrialSJMB12
Shares Gemcitabine, Cisplatin, IMRT / IGRT (modern external beam), Cytotoxic chemotherapy and the tag soc-trials.
- TrialInPACT
Shares Cisplatin, IMRT / IGRT (modern external beam), Cytotoxic chemotherapy and the tag soc-trials.
- TrialACNS1422
Shares Cisplatin, IMRT / IGRT (modern external beam), Cytotoxic chemotherapy and the tag soc-trials.
- TrialESPAC-4
Shares Gemcitabine, Cytotoxic chemotherapy and the tag soc-trials.
- TrialCONKO-001
Shares Gemcitabine, Cytotoxic chemotherapy and the tag soc-trials.
- TrialACNS0333
Shares Cisplatin, IMRT / IGRT (modern external beam), Cytotoxic chemotherapy and the tag soc-trials.