metadat (version 1.4-0)

dat.roever2022: Irinotecan / S-1 Toxicity Dataset

Description

12 studies investigating the occurrence of dose limiting toxicities (DLTs) at different doses of a combination therapy of Irinotecan and S-1.

Usage

dat.roever2022

Format

The data frame contains the following columns:

study	character	study label
year	integer	publication year
dose	numeric	dose (\(\mathrm{mg} / \mathrm{m}^2\))
events	integer	number of DLTs
total	integer	number of patients exposed

Author

Christian Roever,

Concepts

medicine, oncology, dose-response models

Details

A combination therapy of Irinotecan (a topoisomerase 1 inhibitor) and S-1 (a combination of three pharmacological compounds, namely, tegafur, gimeracil, and oteracil potassium) was tested in advanced colorectal and gastric cancer. This dataset contains data from twelve studies investigating this therapy in a Japanese population; it contains the doses investigated, the numbers of patients treated, and the number of dose-limiting toxicities (DLTs) observed. In general, each study investigated several doses according to some dose-escalation scheme.

References

European Medicines Agency (EMA) (2021). Onivyde pegylated liposomal (irinotecan hydrochloride trihydrate) EPAR summary. https://www.ema.europa.eu/en/medicines/human/EPAR/onivyde-pegylated-liposomal

European Medicines Agency (EMA) (2022). Teysuno (tegafur/gimeracil/oteracil) EPAR summary. https://www.ema.europa.eu/en/medicines/human/EPAR/teysuno

Yamada, Y., Yasui, H., Goto, A., et al. (2003). Phase I study of irinotecan and S-1 combination therapy in patients with metastatic gastric cancer. International Journal of Clinical Oncology, 8(6), 374--380. https://doi.org/10.1007/s10147-003-0359-z

Takiuchi, H., Narahara, H., Tsujinaka, T., et al. (2005). Phase I study of S-1 combined with irinotecan (CPT-11) in patients with advanced gastric cancer (OGSG 0002). Japanese Journal of Clinical Oncology, 35(9), 520--525. https://doi.org/10.1093/jjco/hyi148

Inokuchi, M., Yamashita, T., Yamada, H., et al. (2006). Phase I/II study of S-1 combined with irinotecan for metastatic advanced gastric cancer. British Journal of Cancer, 94(8), 11130. https://doi.org/10.1038/sj.bjc.6603072

Nakafusa, Y., Tanaka, M., Ohtsuka, T., et al. (2008). Phase I/II study of combination therapy with S-1 and CPT-11 for metastatic colorectal cancer. Molecular Medicine Reports, 1(6), 925--930. https://doi.org/10.3892/mmr_00000051

Ishimoto, O., Ishida, T., Honda, Y., Munakata, M., & Sugawara, S. (2009). Phase I study of daily S-1 combined with weekly irinotecan in patients with advanced non-small cell lung cancer. International Journal of Clinical Oncology, 14(1), 43--47. https://doi.org/10.1007/s10147-008-0796-9

Ogata, Y., Sasatomi, T., Akagi, Y., Ishibashi, N., Mori, S., & Shirouzu, K. (2009). Dosage escalation study of S-1 and irinotecan in metronomic chemotherapy against advanced colorectal cancer. The Kurume Medical Journal, 56(1+2), 1--7. https://doi.org/10.2739/kurumemedj.56.1

Shiozawa, M., Sugano, N., Tsuchida, K., Morinaga, S., Akaike, M., & Sugimasa, Y. (2009). A phase I study of combination therapy with S-1 and irinotecan (CPT-11) in patients with advanced colorectal cancer. Journal of Cancer Research and Clinical Oncology, 135(3), 365--370. https://doi.org/10.1007/s00432-008-0480-5

Yoshioka, T., Kato, S., Gamoh, M., et al. (2009). Phase I/II study of sequential therapy with irinotecan and S-1 for metastatic colorectal cancer. British Journal of Cancer, 101, 1972--1977. https://doi.org/10.1038/sj.bjc.6605432

Komatsu, Y., Yuki, S., Fuse, N., et al. (2010). Phase 1/2 clinical study of irinotecan and oral S-1 (IRIS) in patients with advanced gastric cancer. Advances in Therapy, 27(7), 483--492. https://doi.org/10.1007/s12325-010-0037-2

Kusaba, H., Esaki, T., Futami, K., et al. (2010). Phase I/II study of a 3-week cycle of irinotecan and S-1 in patients with advanced colorectal cancer. Cancer Science, 101(12), 2591--2595. https://doi.org/10.1111/j.1349-7006.2010.01728.x

Yoda, S., Soejima, K., Yasuda, H., et al. (2011). A phase I study of S-1 and irinotecan combination therapy in previously treated advanced non-small cell lung cancer patients. Cancer Chemotherapy and Pharmacology, 67(3), 717--722. https://doi.org/10.1007/s00280-010-1539-y

Goya, H., Kuraishi, H., Koyama, S., et al. (2012). Phase I/II study of S-1 combined with biweekly irinotecan chemotherapy in previously treated advanced non-small cell lung cancer. Cancer Chemotherapy and Pharmacology, 70(5), 691--697. https://doi.org/10.1007/s00280-012-1957-0

See Also

dat.ursino2021

Examples

# show (some) data
head(dat.roever2022, n=10)

if (FALSE) {
# illustrate data
plot(NA, xlim=range(dat.roever2022$dose), ylim=0:1,
     xlab="dose (mg / m²)", ylab="proportion",
     main="dat.roever2022 (Irinotecan / S-1 data)")
studylab <- unique(dat.roever2022$study)
colvec <- rainbow(length(studylab))
for (i in 1:length(studylab)) {
  idx <- (dat.roever2022$study == studylab[i])
  lines(dat.roever2022[idx,"dose"],
        dat.roever2022[idx,"events"] / dat.roever2022[idx,"total"],
        col=colvec[i], type="b")
}
legend("topleft", studylab, col=colvec, pch=15)
}