Gemcitabine With S-1 May Become New Standard of Care in Japan for Advanced Bilia

Rev. Wayne,

I agree that chemo is an opaque topic to wrap one’s head around.

Cisplatin is one of the chemos in the “platin” family – others are carboplatin and oxaliplatin.

Capecitabine is from a different family – it is the pill form of 5FU.

Gemcitabine is a third chemo.  As another board member, Darragh, recently mentioned, a new chemo derived from gemcitabine – Acelarin – is being tested so in the future gem may have a “family” as well.

These chemos are all used for cholangiocarcinoma and have been tested in clinical trials both singly and in combinations.  Gem-cis became considered a standard of care as a result of a large clinical trial study (ABC-02) that showed it to be more effective for CCA than gem alone.

Gem-cap  is used in an adjuvant (post-surgery) protocol also including radiation that comes from a study called SWOG S0809 if anyone wants to Google it.  In the study, the authors note that their design predates the British study on gem-cis.  Capecitabine is used with radiation because it appears to sensitize cancer cells for better impact by the radiation.  Gem has been used in this way as well, but it is more complicated since it requires infusion which is difficult to manage given radiation is every day.

Gem-cap has been looked at in a bunch of small studies and appears to produce similar results to gem-cis.  What is missing is a large, randomized study.

Regards, Mary

Hi readers,

This report from Japan is really interesting.  It shows via a randomized study with a sufficiently sized sample of patients that gemcitabine plus S-1 is not inferior (in terms of patient outcomes) to gemcitabine plus cisplatin.  Gem-cis is the chemo workhorse combo for our cancer.

S-1 is an oral form of the chemotherapy drug 5-FU.  S-1 is not approved for use in the United States but is used in Asian and European countries.

In the US, a different oral form of 5-FU is used – capecitabine.  There has not yet been a similar head-to-head comparison study between gem-cis and gem-cap, but there have been a few small or nonrandomized studies showing patient outcomes for gem-cap that are similar to the big British study establishing gem-cis as the standard of care for CCA.

Why is this important?  Gem-cap has milder side effects than gem-cis or in chemo-speak, it is “well-tolerated.”

S-1 and capecitabine are two different formulations, so this new study does not really tell us anything specifically about gem-cap.  But hopefully it will spur our researchers to look into whether gem-cap can someday (soon) be considered as standard of care alongside gem-cis.

Regards, Mary