A trial to see if the protein ERCC1 affects how non small cell lung cancer responds to different types of chemotherapy

The team found that for squamous cell  non small cell lung cancer chemotherapy including a platinum drug worked better than chemotherapy that didn’t. But there was little difference for people who have a non squamous cell lung cancer.  

The level of ERCC1 made no difference to how well people did with any type of treatment.

This was a phase 3 trial. 648 people took part.

Researchers put people into 2 groups depending on whether their cancer was squamous cell or non squamous cell.

They also tested a sample of the cancer from everyone for the ERCC1 protein.

People who had squamous cell NSCLC
177 people who had squamous cell NSCLC were put into 1 of 2 groups by a computer (randomised). 

• 87 people had cisplatin and gemcitabine
• 90 had paclitaxel and gemcitabine

The researchers looked at how well treatment worked (a response).  They found the following numbers of people, whose cancer had the ERCC1 protein, responded to treatment:

• 50 out of every 100 people (50%) who had cisplatin and gemcitabine
• 27 out of every 100 people (27.4%) who had paclitaxel and gemcitabine

For those whose cancer didn’t have the protein this was:

• 57 out of every 100 people (57.1%) who had cisplatin and gemcitabine
• 23 out of every 100 people (23.5%) who had paclitaxel and gemcitabine

The team also looked at the average length of time that people lived after treatment. It was:

• just over 10½ months for those who had cisplatin and gemcitabine
• just over 7½ months for those who had paclitaxel and gemcitabine

These results showed that cisplatin was much better than paclitaxel for people who had squamous cell NSCLC. So the data monitoring committee  that supervised the trial:

• advised the researchers to stop recruitment to this part of the trial
• suggested those who were having paclitaxel should change to cisplatin.

People who had non squamous cell NSCLC
471 people who had non squamous cell NSCLC were randomly put into 1 of 2 treatment groups:

• 235 people had cisplatin and pemetrexed
• 236 people had paclitaxel and pemetrexed

The researchers looked at how many people responded to treatment. For those whose cancer had the ERCC1 protein this was:

• 48 out of every 100 people (48.4%) who had cisplatin and pemetrexed
• 33 out of every 100 people (33%) who had paclitaxel and pemetrexed

For those whose cancer didn’t have the protein this was:

• 32 out of every 100 people (32.9%) who had cisplatin and pemetrexed
• 39 out of every 100 people (39%) who had paclitaxel and pemetrexed

The average length of time people lived was:

• just over 9½ months for those who had cisplatin and pemetrexed
• 8 months for those who had paclitaxel and pemetrexed

Using ERCC1 protein results as a biomarker
The trial team also looked at the ERCC1 protein as a biomarker  to try and predict how well the cancer responded and how long people lived after treatment. No difference was found between people whose cancer had the protein and those who didn’t.

The trial team concluded platinum based chemotherapy was best for advanced squamous cell NSCLC. The ERCC1 protein couldn’t be used to predict how well the cancer would respond to treatment or how long people might live after treatment.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed ) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.