Table 2.
Report on all papers about sorafenib and stomatitis.
| Authors | Year | Neoplasia | Cases number |
Stomatitis (%) | Stomatitis grade 1% |
Stomatitis grade 2% | Stomatitis grade 3% | Stomatitis grade 4% | |
|---|---|---|---|---|---|---|---|---|---|
| (1) | Cho et al. [45] | 2013 | Advanced hepatocellular carcinoma A: sorafenib 400 mg twice daily |
A: 99 | A: 4 (4%) | Not reported | Not reported | ||
|
| |||||||||
| (2) | Chrisoulidou et al. [46] | 2015 | Refractory thyroid cancer Sorafenib 400 mg was given orally twice daily continuously, sunitinib 50 mg was given once daily on a 4 weeks of treatment followed by 2-week intervals without therapy, and vandetanib 300 mg was given once daily |
A: 24 | A: 13 (54%) | A: 12 (50%) | A: 1 (4.16%) | ||
|
| |||||||||
| (3) | Grignani et al. [47] | 2015 | Unresectable high-grade osteosarcoma progressing after standard treatment 400 mg sorafenib twice a day together with 5 mg everolimus once a day |
A: 38 | A: 20 (52.63%) | Not reported | Not reported | ||
|
| |||||||||
| (4) | Hainsworth et al. [48] | 2015 | Stage III/IV epithelial ovarian cancer A: paclitaxel 175 mg/m2, 1–3 h IV infusion/carboplatin AUC 6.0, 20 min IV infusion/sorafenib 400 mg PO BID |
A: 43 | A: 16 (37%) | Oral mucositis A: 16 (37%) |
A: 0 | ||
|
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| (5) | Hainsworth et al. [49] | 2013 | Phase II Sorafenib 200 mg PO BID and everolimus 35 mg PO once weekly |
A: 75 | A: 10 (13.3%) | Mucositis/stomatitis: 10/14% Mucositis/stomatitis: 2/3% |
Mucositis/stomatitis: 0 Mucositis/stomatitis: 0 |
||
|
| |||||||||
| (6) | Lee et al. [6] | 2009 | Retrospective study A: sorafenib 400 mg twice daily for RCC and HCC B: sunitinib 50 mg daily, consisting of 4 weeks of treatment followed by a 2-week rest period in cycles of 6 weeks for RCC and GIST |
A: 109 B: 119 |
A: 28 (26%) B: 43 (36%) |
Not reported | Not reported | ||
|
| |||||||||
| (7) | Marschner et al. [33] | 2017 | mRCC A: sorafenib B: sunitinib |
A: 25 B: 152 |
A: 3 (12.0%) B: 29 (23.2%) |
A: 2 (8%) B: 27 (17.7%) |
A: 1 (4.0%) B: 2 (1.6%) |
||
|
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| (8) | Meyer et al. [50] | 2017 | Unresectable HCC A: sorafenib 660 mg |
A: 157 | A: 41 (26%) | A: 36 (23%) | A: 5 (3%) | ||
|
| |||||||||
| (9) | Porta et al. [51] | 2011 | mRCC A: sunitinib B: sorafenib |
A: 85 B: 60 |
A: 50 (58.8%) B: 16 (26.7%) |
A: 48 (56.4%) B: 16 (26.7%) |
A: 2 (2.4%) B: 0 |
||
|
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| (10) | Richly et al. [52] | 2006 | Refractory solid tumors A: sorafenib 100 mg + doxorubicin B: sorafenib 200 mg + doxorubicin C: sorafenib 400 mg + doxorubicin D: sorafenib 400 mg + doxorubicin |
A: 6 B: 6 C: 12 D: 10 |
TOT 11 (32%) | Not reported | A: 3 (50%) B: - C: 6 (50%) D: 2 (20%) |
||
|
| |||||||||
| (11) | Schwartzberg et al. [53] | 2013 | Advanced breast cancer A: sorafenib (400 mg, twice daily) |
A: 79 | A: 27 (34.1%) | A: 17 (21.5%) | A: 10 (12.65%) | ||
|
| |||||||||
| (12) | Shacham-Shmueli et al. [54] | 2012 | Advanced solid tumors A: sorafenib 100 mg BID (50 mg tablets) + infusion regimen B: sorafenib 200 mg BID (50 mg tablets) + infusion regimen C: sorafenib 400 mg BID (50 mg tablets) + infusion regimen D: sorafenib 400 mg BID (50 mg tablets) + bolus A regimen E: sorafenib 400 mg BID (200 mg tablets) + infusion regimen F: sorafenib 400 mg BID (200 mg tablets) + bolus B regimen |
A: 10 B: 7 C: 6 D: 9 E: 6 F: 9 |
A: - B: - C: - D: 3 (33%) E: - F: - |
Not reported | A: - B: - C: - D: 3 (33%) E: - F: - |
||
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| (13) | Sho et al. [55] | 2017 | Advanced hepatocellular carcinoma A: 250 mg/m2 of 5-FU and sorafenib 800 mg daily B: 350 mg/m2 of 5-FU and sorafenib 800 mg daily C: 450 mg/m2 of 5-FU and sorafenib 800 mg daily |
A: 3 B: 3 C: 6 |
A: 0 B: 1 C: 3 |
A: 0 B: 1 C: 2 |
A: - B: - C: 1 |
||
|
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| (14) | Ueda et al. [56] | 2013 | Metastatic renal cell carcinoma A: axitinib B: sorafenib |
A: 359 B: 355 |
A: 54 (15.04%) B: 44 (12.39%) |
A: 49 (13.64%) B: 43 (12.11%) |
A: 5 (1.39%) B: 1 (0.28%) |
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| (15) | Williamson et al. [57] | 2010 | Advanced and metastatic squamous cell carcinoma of the head and neck A: sorafenib orally at 400 mg twice daily on continuous basis in 28-day cycles |
A: 41 | A: 2 (4.9%) | Not reported | A: 2 | ||
|
| |||||||||
| (16) | Zhao et al. [44] | 2013 | Locally advanced clear cell renal carcinoma A: sorafenib 400 mg orally twice daily for 4-week cycle B: sunitinib 50 mg orally daily for a 6-week cycle |
A: 20 B: 23 |
A: 8 (40%) B: 7 (30%) |
Not reported | Not reported | ||
|
| |||||||||
| Total | 1218 | 250 (20.52%) | |||||||
|
| |||||||||
| Total with grade | 830 | 174 (20.96%) | 155 (18.67%) | 19 (2,28%) | |||||
|
| |||||||||
| Total not reporting grade∗ | 266 | 60 (22.55%) | Not reported | Not reported | |||||
|
| |||||||||
| Total reporting only grade >2∗∗ | 122 | 16 (13.11%) | Not reported | 16 (13.11%) | |||||
Note. ∗Cho et al. (2013) [45], Grignani et al. (2015) [47], Lee et al. (2009) [6], and Zhao et al. (2013) [44] did not report the grade of stomatitis; ∗∗Richly et al. (2006) [52], Shacham-Shmueli et al. (2012) [54], and Williamson et al. (2010) [57] reported the incidence rates limited to grade 3 and grade 4 treatment-related toxicities; for this reason, data about cases of stomatitis and stomatitis grades 1 and 2 are lower than real.