Table 1.
Report on all papers about sunitinib and stomatitis.
| Authors | Year | Neoplasia | Number of cases | Stomatitis number |
Stomatitis grade 1 |
Stomatitis grade 2 | Stomatitis grade 3 | Stomatitis grade 4 | |
|---|---|---|---|---|---|---|---|---|---|
| (1) | Arakawa-Todo et al. [18] | 2013 | Metastatic renal cell carcinoma A: sunitinib 50 mg once daily was given in repeated 6-week cycles of 4 weeks followed by 2 weeks off |
A: 15 | TOT: 9 (60%) | A: 9 (60%) | A: 0 | ||
|
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| (2) | Armstrong et al. [19] | 2016 | Metastatic nonclear renal cell carcinoma A: sunitinib 50 mg/day; 6-week cycles of 4 weeks with treatment followed by 2 weeks without treatment |
A: 51 | A: 14 (27.45%) | A: 14 (27%) | A: 0 | ||
|
| |||||||||
| (3) | Bang et al. [20] | 2011 | Advanced gastric cancer A: sunitinib 50 mg/day for 4 weeks on treatment and 2 weeks off |
A: 78 | A: 28 (35.9%) | A: 27 (34.6%) | A: 1 (1.3%) | ||
|
| |||||||||
| (4) | Cardoso et al. [21] | 2012 | HER2-positive metastatic breast cancer A: sunitinib 37.5 mg (starting dose across sunitinib combination studies) once daily by oral capsule on schedule 2/1 |
A: 25 | A: 12 (48%) | A: 9 (36%) | A: 3 (12%) | ||
|
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| (5) | Carrato et al. [22] | 2013 | Metastatic colorectal cancer randomized phase III trial A: sunitinib plus FOLFIRI (fluorouracil, leucovorin, and irinotecan) |
A: 386 | A: 35 (9%) | Not reported | A: 35 (9%) | ||
|
| |||||||||
| (6) | Dirican et al. [23] | 2013 | Metastatic renal cell carcinoma A: sunitinib: 50 mg per day was administered in repeated 6-week cycles of daily therapy for 4 weeks, followed by 2 weeks off |
A: 23 | A: 6 (26.1%) | A: 4 (17.4%) | A: 2 (8.7%) | ||
|
| |||||||||
| (7) | Domagala-Haduch et al. [24] | 2016 | Advanced renal cell carcinoma A: sunitinib: 50 mg/day for 4 weeks, and then it is stopped for 2 weeks |
A: 39 | A: 13 (33.3%) | A: 11 (28.2%) | A: 2 (5.1%) | ||
|
| |||||||||
| (8) | Goodman et al. [25] | 2007 | Refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma A: sunitinib: 50 mg given daily for 4 weeks followed by a 2-week rest period (schedule 4/2) |
A: 202 | A: 58 (29%) | A: 56 (27.7%) | A: 2 (1%) | ||
|
| |||||||||
| (9) | Grünwald et al. [26] | 2011 | Metastatic renal cell carcinoma (RCC) IL-21 administered subcutaneously (s.c.) in combination with sunitinib 50 mg once daily (OD) orally at the 4 weeks on/2 weeks off A: rIL-21 3 μg/kg B: rIL-21 10 μg/kg |
A: 5 B: 4 |
TOT: 4 (80%) TOT: 1 (25%) |
A: 4 (80%) B: 1 (25%) |
A: 0 B: 0 |
||
|
| |||||||||
| (10) | Hong et al. [27] | 2009 | Advanced renal cell carcinoma patients A: sunitinib (50 mg for 4 weeks on/2 weeks off schedule) B: sunitinib 37.5 mg daily continuous dosing |
A: 62 B: 14 |
TOT: 48 (63.2%) | TOT: 40 (64.5%) | TOT: 8 (10.5%) | ||
|
| |||||||||
| (11) | O'Donnell [28] | 2011 | Advanced renal cell carcinoma (RCC) A: sunitinib Seven patients started at a dose of 50 mg daily and nine patients started at a dose of 37.5 mg daily. The remaining three patients started at 25 mg daily |
TOT: 19 | A: 8 (42.1%) | A: 7 (36.9%) | A: 1 (5.26%) | ||
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| (12) | Kim et al. [29] | 2014 | The starting sunitinib dose was 37.5 and 50 mg for 12 and 22 patients, respectively. A 4 weeks on/2 weeks off regimen was followed for 31 patients; a 2 weeks on/2 weeks off regimen for one patient; and a daily regimen for two patients | A: 34 | A: 13 (39%) | A: 10 (30%) | A: 3 (9%) | ||
|
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| (13) | Lee et al. [30] | 2010 | Metastatic renal cell carcinoma A: 6-week cycles of sunitinib treatment (50 mg once daily for 4 weeks on and 2 weeks off schedule) |
A: 21 | A: 9 (42.8%) | A: 5 (23.8%) | A: 4 (19%) | ||
|
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| (14) | Lee et al. [31] | 2015 | treatment-naïve patients with clear cell type metastatic renal cell carcinoma (mRCC) A: sunitinib 50 mg, “2 weeks on, 1 week off” B: sunitinib 50 mg, 4 weeks on, 2 weeks off |
A: 38 B: 36 |
A: 27 (71%) B: 31 (86%) |
A: 26 (68.4%) B: 27 (75%) |
A: 1 (3%) B: 4 (11%) |
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| (15) | Lee et al. [32] | 2013 | A: SU: 37.5 mg/die + oral capecitabine 800 mg/m2 + cisplatin 60 mg/m2 B: SU: 37.5 mg/die + oral capecitabine 1,000 mg/m2 + cisplatin 60 mg/m2 C: SU: 25 mg/die + oral capecitabine 1,000 mg/m2 + cisplatin 80 mg/m2 D: SU: 37.5 mg/die + oral capecitabine 800 mg/m2 + oxaliplatin 110 mg/m2 E: SU: 37.5 mg/die + oral capecitabine 1,000 mg/m2 + oxaliplatin 110 mg/m2 F: SU: 25 mg/die + oral capecitabine 1,000 mg/m2 + oxaliplatin 110 mg/m2 |
A: 6 B: 7 C: 15 D: 23 E: 3 F: 22 |
A: 5 (83.3%) B: 3 (42.9%) C: 8 (53.3%) D: 10 (43.5%) E: 1 (33.3%) F: 7 (31.8%) |
A: 5 (83.3%) B: 3 (42.9%) C: 6 (40%) D: 10 (43.5%) E: 1 (33.3%) F: 7 (31.8%) |
A: 0 B: 0 C: 2 (13.3%) D: 0 E: 0 F: 0 |
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| (16) | 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 | ||
|
| |||||||||
| (17) | 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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| (18) | Mir et al. [34] | 2016 | mRCC A: sunitinib 50 mg once daily for 4 weeks |
A: 50 | A: 24 (12%) | A: 20 (40%) | A: 4 (2%) | ||
|
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| (19) | Patel et al. [35] | 2009 | Advanced renal cell carcinoma A: temsirolimus 15 mg was administered by intravenous (I.V.) infusion once weekly, and sunitinib 25 mg was administered orally once daily for 4 weeks, followed by a 2-week rest period. |
A: 3 | A: 1 | A: 1 (33.3%) | A: 0 | ||
|
| |||||||||
| (20) | Porta et al. [36] | 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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| (21) | Rock et al. [37] | 2007 | GIST A: sunitinib 50 mg |
A: 202 | A: 58 (29%) | A: 56 (27.7%) | A: 2 (1%) | ||
|
| |||||||||
| (22) | Socinski et al. [38] | 2008 | Advanced non-small cell lung cancer A: sunitinib 50 mg/d for 4 weeks followed by 2 weeks of no treatment in a 6-week cycle |
A: 63 | A: 27 (43%) | A: 27 (43%) | A: 0 | ||
|
| |||||||||
| (23) | Sonpavde et al. [39] | 2010 | Metastatic castration-resistant prostate cancer A: sunitinib 50 mg/day: 4 weeks on followed by 2 weeks off |
A: 36 | A: 2 (5.7%) | A: 1 | A: 1 | ||
|
| |||||||||
| (24) | Sternberg et al. [40] | 2015 | Metastatic renal cell carcinoma (mRCC) A: oral sunitinib 50 mg/day on a 4 weeks on/2 weeks off schedule |
A: 521 | A: 192 (37%) | A: 159 (31%) | A: 33 (6%) | ||
|
| |||||||||
| (25) | Van Der Veldt et al. [41] | 2008 | Advanced RCC A: sunitinib 50 mg daily for 4-week treatment followed by 2-week rest period in a cycle of 6 weeks |
A: 82 | A: 58 (70.73%) | A: 51 (62%) | A: 7 (9%) | ||
|
| |||||||||
| (26) | Yildiz et al. [42] | 2011 | Advanced renal cell carcinoma A: sunitinib 37.5 mg daily B: sunitinib 25 mg |
A: 67 | A: 36 (51%) | A: 36 (51%) | A: 0 | ||
|
| |||||||||
| (27) | Yoo et al. [43] | 2010 | Renal cell carcinoma A: sunitinib 50 and 37.5 mg daily |
A: 65 | A: 37 (57%) | A: 31 (50%) | A: 6 (10%) | ||
|
| |||||||||
| (28) | Zhao et al. [44] | 2013 | Locally advanced clear cell renal carcinoma A: sorafenib 400 mg orally twice daily for a 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 | 2.596 | 914 (35.2%) | |||||||
|
| |||||||||
| Total with grade | 2.068 | 829 (40.08%) | 739 (35.73%) | 90 (5.35%) | |||||
|
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| Total not reporting grade∗ | 142 | 50 (3.52%) | Not reported | Not reported | |||||
|
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| Total reporting only grade >2∗∗ | 386 | 35 (0.06%) | Not reported | 35 (0.06%) | |||||
Note. ∗Carrato et al. (2013) [22] did not report the grade of stomatitis; ∗∗Lee et al. (2009) [6] and Zhao et al. (2013) [44] 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.