Duration of previous treatment as a prognostic factor in metastatic colorectal cancer treated with trifluridine/tipiracil

Skuja, Elīna; Gerina-Berzina, Aija; Hegmane, Alinta; Zvirbule, Zaneteï¿1⁄2; Vecvagare, Eva; Purkalne, Gunta

doi:10.3892/mco.2018.1600

Cited by 13 publications

(21 citation statements)

References 7 publications

(5 reference statements)

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“…The reasons for these differences are unclear but may reflect differing clinical practice in the evaluation and recording of ECOG-PS scores in different countries, or may suggest that patients included in the German and UK NPPs were at a more advanced stage of disease at enrolment. The number and type of previous treatments observed were similar to those reported in observational studies from the Netherlands [14], Japan [15], Latvia [16] and Germany [17]. However, a smaller proportion of the patients receiving trifluridine/tipiracil in this analysis had at least 4 prior treatment regimens (19%) than in the RE-COURSE trial [10] (60%).…”

Section: Discussionsupporting

confidence: 79%

“…We observed a wide range of treatment regimens at all lines of therapy. Similar to the populations reported in Skuja et al [16] and the RE-COURSE trial [10], most (≥90%) patients had previously received 5-FU and irinotecan. First line regimens were most commonly based on FOLFOX, FOLFIRI or CAPOX.…”

Section: Discussionsupporting

confidence: 74%

“…The demographics and clinical characteristics of patients enrolled in the NPP who went on to receive at least one dose of trifluridine/ tipiracil were broadly similar to those not receiving trifluridine/tipiracil. Furthermore, patients enrolled had similar demographic characteristics (median age, sex) to those in the RECOURSE trial [10] and several real-world studies [13][14][15][16]. However, there was a higher proportion of patients in the RECOURSE trial [10] and the Italian single-centre compassionate use programme (CUP) [13] with ECOG-PS scores of 0 (56 and 63% respectively) than patients enrolled in the UK NPP (28% of patients receiving ≥1 dose of trifluridine/tipiracil, 14% of patients not receiving trifluridine/tipiracil).…”

Section: Discussionmentioning

confidence: 99%

“…Subsequent post-hoc analysis of RECOURSE trial data has demonstrated the clinical efficacy and tolerability of trifluridine/tipiracil in various subgroups [11] and clinically meaningful improvements in quality-adjusted survival [12]. There is further evidence supporting the clinical effectiveness and tolerability of trifluridine/tipiracil in various geographies [13][14][15][16][17][18].…”

Section: Introductionmentioning

confidence: 97%

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Review of metastatic colorectal cancer treatment pathways and early clinical experience of trifluridine/tipiracil in the UK named patient programme

Iveson

Carter²,

Shiu

et al. 2020

BMC Cancer

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Background: The standard first-and second-line chemotherapy backbone regimens for metastatic colorectal cancer (mCRC) are 5-fluorouracil (5-FU)/capecitabine-based with addition of irinotecan or oxaliplatin. Until recently, evidence for optimal sequencing post second-line was sparse. Trifluridine/tipiracil (indicated for mCRC and gastric cancer after standard chemotherapies) was made available to UK patients via a named patient programme (NPP) before receiving marketing authorisation in Europe in 2016, allowing characterisation of UK treatment pathways, and evaluation of trifluridine/tipiracil in a UK non-trial population.Methods: Data collected routinely for the NPP were analysed to describe the patient demographics, clinical characteristics and treatment pathways. Patients eligible for the programme were adults (≥18 years) with histologically or cytologically confirmed mCRC who had previously received chemotherapy treatment(s).Results: Of the 250 eligible patients enrolled in the NPP, 194 patients received ≥1 dose of trifluridine/tipiracil and 56 patients did not receive trifluridine/tipiracil. The following results are reported first for patients who received trifluridine/tipiracil and second for those who did not receive trifluridine/tipiracil: median (IQR) age was 63.0 (54.0-69.0) and 62.0 (54.8-69.0) years; Eastern Cooperative Oncology Group performance status score was 0 for 28 and 14%, 1 for 65 and 70%, 2 for 7 and 16%. In terms of previous systemic treatments 47 and 43% had 2 prior lines of therapy. FOLFOX-, FOLFIRI-and CAPOX-based therapies were the most common first-line regimens in patients receiving trifluridine/tipiracil (37, 35 and 21%, respectively), and in patients not receiving trifluridine/tipiracil (41, 30 and 20%, respectively). Second-line treatment regimens in patients receiving and not receiving trifluridine/tipiracil were most commonly FOLFIRI-based (48 and 41%, respectively) and respectively). Patients received a median of 2 cycles of trifluridine/tipiracil with a median treatment duration of 1.8 (95% CI: 1.8-2.4) months. In patients who discontinued treatment due to disease progression, the median progression-free duration was 2.8 (95% CI: 2.4-2.9) months. Conclusions:The results highlight the number of treatment pathways used to treat mCRC in routine UK clinical practice prior to the marketing authorisation and National Institute for Health and Care Excellence approval of trifluridine/tipiracil and highlight the lack of clinical guidelines for mCRC.

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Section: Discussionsupporting

confidence: 79%

Section: Discussionsupporting

confidence: 74%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 97%

See 2 more Smart Citations

Review of metastatic colorectal cancer treatment pathways and early clinical experience of trifluridine/tipiracil in the UK named patient programme

Iveson

Carter²,

Shiu

et al. 2020

BMC Cancer

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“…Several compassionate use programs of FTD/TPI across Europe, the USA, and Asia have been conducted and in summary they underline the efficacy and safety of FTD/TPI in a real-world population with refractory mCRC [17][18][19][20][21].…”

Section: Studies Favoring Ftd/tpi Treatment For Mcrc Patientsmentioning

confidence: 99%

Metastatic Colorectal Carcinoma after Second Progression and the Role of Trifluridine-Tipiracil (TAS-102) in Switzerland

et al. 2020

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Background: Metastatic colorectal carcinoma (mCRC) is one of the most prevalent types of cancer worldwide. After tumor progression with first-and second-line treatment, trifluridine (FTD) and tipiracil (TPI) has been shown to be a treatment option. Summary: Data from a pivotal phase 3 trial (RE-COURSE) and an ongoing phase 3b trial (PRECONNECT) have shown that, in mCRC patients who experienced disease progression after 2 lines of standard therapy, treatment with FTD/TPI is safe and efficacious. Other third-line options include regorafenib, rechallenge with previous treatment lines or personalized approaches based on comprehensive molecular profiling. Randomized trials or sequential studies aiming for the right treatment sequence or predefined subtypes for FTD/TPI or regorafenib as well for rechallenge are missing. However, FTD/TPI as well as regorafenib are recommended by the current ESMO, German S3, and National Comprehensive Cancer Network (NCCN) guidelines in the same situation, thus offering physicians a number of alternatives for the treatment of mCRC patients after the second progression. Key Message: This narrative review summariz-es published data and their impact for FTD/TPI as well for regorafenib and rechallenge chemotherapy in clinical practice settings of refractory situations of colorectal cancer.

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Time‐varying prognostic value of primary tumor sidedness in metastatic colorectal cancer: A population‐based study and meta‐analysis

Kruijssen

Kuil

Vink

et al. 2022

Intl Journal of Cancer

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We studied the prognostic value of primary tumor sidedness in metastatic colorectal cancer over time and across treatment lines. Population data on synchronous metastatic colorectal cancer patients were extracted from the Netherlands Cancer Registry and SEER database. Pubmed, EMBASE and Cochrane library were searched for prospective studies on metastatic colorectal cancer to conduct a meta‐analysis. Inclusion criteria consisted of metastatic disease, systemic treatment with palliative intent and specification of primary tumor location. Data were pooled using a random‐effects model. For the population‐based data, multivariable Cox models were constructed. The Grambsch‐Therneau test was conducted to evaluate the potential time‐varying nature of sidedness. Meta‐regression incorporating treatment‐line as variable was conducted to test the pre‐specified hypothesis that the prognostic value of sidedness varies over time. Analysis of 12 885 and 16 160 synchronous metastatic colorectal cancer patients registered in the Netherlands Cancer Registry and SEER database, respectively, indicated a time‐varying prognostic value of sidedness (P < .01). Thirty‐one studies were selected for the meta‐analysis (9558 patients for overall survival analysis). Pooled univariable hazard ratioleft‐sided/right‐sided for overall survival was 0.71 (95% CI: 0.65‐0.76) in 1st‐line, 0.76 (0.54‐1.06) in 2nd‐line and 1.01 (0.86‐1.19) in 3rd‐line studies. Hazard ratios were significantly influenced by treatment line (P = .035). The prognostic value of sidedness of the primary tumor in metastatic colorectal cancer patients treated with palliative systemic therapy decreases over time since diagnosis, suggesting that sidedness may not be a useful stratification factor in late‐line trials. This decrease in prognostic value should be taken into account when providing prognostic information to patients.

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Duration of previous treatment as a prognostic factor in metastatic colorectal cancer treated with trifluridine/tipiracil

Cited by 13 publications

References 7 publications

Review of metastatic colorectal cancer treatment pathways and early clinical experience of trifluridine/tipiracil in the UK named patient programme

Review of metastatic colorectal cancer treatment pathways and early clinical experience of trifluridine/tipiracil in the UK named patient programme

Metastatic Colorectal Carcinoma after Second Progression and the Role of Trifluridine-Tipiracil (TAS-102) in Switzerland

Time‐varying prognostic value of primary tumor sidedness in metastatic colorectal cancer: A population‐based study and meta‐analysis

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