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Results of randomised phase II studies comparing S16020 with methotrexate in patients with recurrent head and neck
1Service d'Oncology, CHU J. Minjoz, Besançon, France. xpivot@chu-besancon.fr
Background:
The purpose of this study was to carry out two randomised phase II trials of S16020, a new olivacine derivative, tested as a single agent in patients with recurrent head and neck cancer, using methotrexate as the control arm to validate the results.
Patients And Methods:
S16020 at either 80 or 100 mg/m2 was administered as a 3-h infusion every 3 weeks. Methotrexate, 40 or 50 mg/m2, was given by bolus injection, weekly for a minimum of 6 weeks. In total, 36 patients were entered in the randomised studies (25 in an initial study, 11 in a confirmatory study) of whom 24 received S16020 and 12 received methotrexate.
Results:
A scheduled interim analysis showed one patient having a non-confirmed objective response with S16020 and three patients having a confirmed objective response with methotrexate. In the methotrexate group, there were no patients with severe non-haematological toxicity. With S16020, there was a high incidence of severe non-haematological toxicities, including asthenia, oedema of the face, oedema and pain at the tumour sites and erythematous rash; consequently, both studies were stopped.
Conclusions:
Both studies were stopped due to the poor anticipated benefit/risk ratio for S16020, although time to progression and overall survival time were similar in both treatment arms.
Insights
The new cancer drug S16020 showed poor results in head and neck cancer trials. It was stopped early due to severe side effects and limited patient benefit compared to methotrexate.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Recurrent head and neck cancer presents significant treatment challenges.
- Evaluating novel therapeutic agents is crucial for improving patient outcomes.
Purpose of the Study:
- To assess the efficacy and safety of S16020, a novel olivacine derivative, in patients with recurrent head and neck cancer.
- To compare S16020 against methotrexate in a randomized phase II clinical trial setting.
Main Methods:
- Two randomized phase II trials were conducted.
- Patients received either S16020 (80 or 100 mg/m2 every 3 weeks) or methotrexate (40 or 50 mg/m2 weekly).
- A total of 36 patients were enrolled.
Main Results:
- S16020 demonstrated a low objective response rate (1 confirmed response out of 24 patients).
- Methotrexate showed a higher response rate (3 confirmed responses out of 12 patients) with no severe non-hematological toxicity.
- S16020 was associated with significant non-hematological toxicities, including asthenia and edema.
Conclusions:
- Both trials involving S16020 were terminated prematurely.
- The poor benefit/risk profile of S16020 led to the discontinuation of its investigation.
- Despite early termination, time to progression and overall survival were comparable between arms.
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