***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: PURPOSE To evaluate chronic xerostomia and tumor control 18 and 24 months after initial treatment with amifostine in a r and omized controlled trial of patients with head- and -neck cancer ; at 12 months after radiotherapy ( RT ) , amifostine had been shown to reduce xerostomia without changing tumor control . METHODS AND MATERIAL S Adults with head- and -neck cancer who underwent once-daily RT for 5 - 7 weeks ( total dose , 50 - 70 Gy ) received either  open-label amifostine ( 200 mg/m2 i.v . ) 15 - 30 min before each fraction of radiation ( n = 150 ) or RT alone ( control ; n = 153 ) . RESULTS Amifostine administration was associated with a reduced incidence of Grade > or = 2 xerostomia over 2 years of follow-up ( p = 0.002 ) , an increase in the proportion of patients with meaningful ( > 0.1 g ) unstimulated saliva production at 24 months ( p = 0.011 ) , and reduced mouth dryness scores on a patient benefit question naire at 24 months ( p < 0.001 ) . Locoregional control rate , progression-free survival , and overall survival were not significantly different between the amifostine group and the control group . CONCLUSIONS Amifostine administration during head- and -neck RT reduces the severity and duration of xerostomia 2 years after treatment and does not seem to compromise locoregional control rates , progression-free survival , or overall survival A r and omized phase 2 study was performed to investigate the efficacy/toxicity of combining concomitant boost radiation and weekly carboplatin/paclitaxel with or without amifostine in patients with locally advanced squamous cell carcinoma of the head and neck ( SCCHN ) PURPOSE Promising results in a r and omized phase II trial with the hypoxic cytotoxin tirapazamine ( TPZ ) combined with cisplatin ( CIS ) and radiation led to this phase III trial . PATIENTS AND METHODS Patients with previously untreated stage III or IV ( excluding T1 - 2N1 and M1 ) squamous cell carcinoma of the oral cavity , oropharynx , hypopharynx , or larynx were r and omly assigned to receive definitive radiotherapy ( 70 Gy in 7 weeks ) concurrently with either CIS ( 100 mg/m(2 ) ) on day 1 of weeks 1 , 4 , and 7 or CIS ( 75 mg/m(2 ) ) plus TPZ ( 290 mg/m(2)/d ) on day 1 of weeks 1 , 4 , and 7 and TPZ alone ( 160 mg/m(2)/d ) on days 1 , 3 , and 5 of weeks 2 and 3 ( TPZ/CIS ) . The primary end point was overall survival ( OS ) . The planned sample size was 850 , estimated to result in 334 deaths , which would provide 90 % power to detect a difference in 2-year survival rates of 60 % v 70 % for CIS versus TPZ/CIS , respectively ( hazard ratio = 0.69 ) . RESULTS Eight hundred sixty-one patients were accrued from 89 sites in 16 countries . In an intent-to-treat analysis , the 2-year OS rates were 65.7 % for CIS and 66.2 % for TPZ/CIS ( TPZ/CIS -- CIS : 95 % CI , -5.9 % to 6.9 % ) . There were no significant differences in failure-free survival , time to locoregional failure , or quality of life as measured by Functional Assessment of Cancer Therapy-Head and Neck . CONCLUSIONS We found no evidence that the addition of TPZ to chemoradiotherapy , in patients with advanced head and neck cancer not selected for the presence of hypoxia , improves OS In a r and omized phase II trial in Germany , we investigated the clinical and economic impact of amifostine protection against the hematological and oral toxicities of carboplatin administered concurrently with st and ard fractions of radiotherapy . 28 patients with squamous cell carcinomas of the head and neck received  adjunctive or primary radiotherapy ( 5 days per week with daily fractions of 2 Gy , up to a total dose of 60 Gy ) in conjunction with carboplatin ( 70 mg/m2 ) on days 1–5 and days 21–26 . All patients received radiation encompassing at least 75 % of the major salivary gl and s. Patients were r and omized to receive radiation and carboplatin ( RCT ) alone or RCT preceded by rapid infusion of amifostine ( 500 mg ) on days carboplatin was administered . The 14 patients who received  amifostine , in comparison to 14 patients in the control arm , had significantly fewer episodes of grade 3 or 4 thrombocytopenia ( p = 0.001 ) , mucositis ( p = 0.001 ) , and xerostomia ( p = 0.001 ) . The patients receiving amifostine accrued significantly lower supportive care costs for re sources related to infection ( $ 241 vs. $ 1,275 , p < 0.01 ) , red blood cell and platelet support ( $ 286 vs. $ 1,276 p = 0.06 ) alimentation ( $ 343 vs. $ 894 , p = . 01 ) , and hospitalization ( $ 286 vs. $ 2,429 , p < 0.01 ) . Overall , including the costs of amifostine , mean per patient supportive care costs were $ 4,401 for the amifostine group and $ 5,873 ( p = .02 ) for the control group . Our results from a r and omized phase II trial indicate that selective cytoprotection with amifostine potentially offers clinical and economic benefits in patients with advanced head and neck cancer receiving radiochemotherapy . Additional economic studies alongside r and omized phase III trials and from other countries are needed The authors discuss the results of 3 studies of their group reflecting the possible role of amifostine in simultaneous radiochemotherapy ( RCT ) of advanced head and neck cancer . In a controlled phase II trial ( 1995 through 1996 ) , 39 patients were included in this pilot investigation . A control group ( n = 14 ) received simultaneous RCT of the head and neck region with an irradiation dose of 60 Gy and 2 cycles of carboplatin ( 700 mg/m(2 ) cumulative dose ) . Twenty-five patients received the same basic therapy and an additional 500-mg dose of amifostine before each chemotherapy . Amifostine was administered less than 45 minutes before the end of radiotherapy . The authors observed a dramatic reduction of typical radiotherapy-associated toxicities ( mucositis , xerostomia , loss of taste , dysphagia ) . The hematologic side effects ( leukocytopenia , anemia , thrombocytopenia ) also were decreased significantly . The overall survival rate and locoregional control of both groups were comparable after 12 months . In a controlled intensification trial ( 1997 through 1999 ) , the authors included 76 consecutive patients ( 69 men , 7 women ) with pharyngeal cancer ( oropharynx , n = 33 ; hypopharynx , n = 43 ) . The tumors were characterized as unresectable and locally advanced without distant metastasis . All patients received a conventional radiotherapy ( 2-Gy single dose , daily fractionation ) up to doses of 60 Gy and an additional 10 Gy as a boost in the tumor-infiltrated region . A dose of carboplatin , 70 mg/m(2 ) , was given to a group of 45 patients on days 1 through 5 and 29 through 33 of radiotherapy ( RCT arm ) . The result ing cumulative dose was 700 mg/m(2 ) . A group of 31 patients ( RCT intens arm ) received the same dose of carboplatin on days 1 through 5 , 22 through 26 , and 43 through 47 or 1 through 5 , 15 through 19 , 29 through 33 , and 43 through 47 of radiotherapy ( cumulative dose 1.05 to 1.40 mg/m(2 ) ) . All patients received 500 mg of amifostine before each carboplatin administration . If the tumor volume was less than 20 cm(3 ) , we observed an increased 1-year overall survival rate ( 91 % v 71 % ) and time to progression ( 17 months v 10 months ) . If the tumor volume was greater than 20 cm(3 ) , we observed comparable treatment results in both groups ( 1-year survival rate , 60 % v 61 % ; time to progression , 13 months v 12 months ) . In a long-term follow-up investigation ( 1999 through 2000 ) , 531 patients ( 89 women , 442 men ) were analyzed according to their toxicities during regular follow-up investigations at our outpatient facility . All patients were treated by surgery or radio(chemo)therapy because of an advanced head and neck cancer . A total of 218 of 531 patients received the antineoplastic therapy without cytoprotection . An additional 313 patients received their RCT  combined with amifostine administration before administration of the radiosensitizer . A significant influence of cytoprotection was registered in the following toxicities : xerostomia , fibrosis , loss of taste , and dysphagia . No impact was seen on the development of interstitial lymph edema and esophageal stenosis .  Amifostine could be integrated in simultaneous radiochemotherapy of advanced head and neck cancer patients . The authors favor the administration of amifostine before chemotherapeutics alone . Selective cytoprotection could decrease the main acute toxicities ( mucositis , xerostomia , dysphagia ) as well as late side effects ( xerostomia , loss of taste , fibrosis ) of this form of combined treatment . The enhanced therapeutic index may be changed into a prognostic benefit for selected patients with unresectable tumors , if the volume is smaller than 20 cm(3 ) A prospect i ve r and omized study is comparing intravenous ( IV ; arm A ) versus subcutaneous ( SC ; arm B ) administration of amifostine in patients receiving radiotherapy for head and neck cancer . Main eligibility criteria were newly diagnosed squamous cell head and neck cancer , inclusion of at least 75 % of both parotid gl and s within radiation fields that would receive at least 40 Gy , and no evidence of distant metastasis . Prophylactic use of pilocarpine and concomitant chemotherapy were prohibited . Intravenous administration of amifostine is 200 mg/m2/d in a short 3-minute infusion 15 to 30 minutes before each fraction of radiotherapy . Subcutaneous administration is 500 mg/d in two , slow 1.25-mL injections at two different sites 20 to 60 minutes before each radiotherapy fraction .  Antiemetic treatment  and blood pressure monitoring are required in both arms . As of April 25 , 2002 , 111 of the 292 required patients were included . Data are available for the first 54 patients .  Acute toxicity included nausea/vomiting ( 12 % for arm A ; 13 % for arm B ) , hypotension ( 6 % in arm A ; 0 % in arm B ) , skin rash ( 15 % in arm A ; 16 % in arm B ) , and asthenia ( 4 % in arm A ; 0 % in arm B ) . Compliance with amifostine administration was 70 % in arm A ( IV ) and 80 % in arm B ( SC ) . The rate of acute xerostomia ( > or = grade 2 ) was 23 % in arm A and 19 % in arm B. These preliminary results indicate that tolerance is better with SC than IV administration , particularly because of the absence of hypotension . The absence of hypotension with SC administration facilitates patient monitoring and management in radiotherapy departments . More patients and data are required to assess the long-term efficacy of SC administration on acute and late xerostomia PURPOSE Salivary gl and impairment is a well-recognized side effect following high-dose radioiodine treatment ( HD-RIT ) . Since differentiated thyroid cancer has a good prognosis , reduction of long-term side effects is important . Therefore , the effect of amifostine was studied in HD-RIT . PATIENTS AND METHODS Parenchymal function was assessed by quantitative salivary gl and scintigraphy performed prospect ively in 50 patients with differentiated thyroid cancer before and 3 months after HD-RIT with either 3 GBq iodine ( (131)I ) ( n=21 ) or 6 GBq (131)I ( n=29 ) in a double-blind , placebo-controlled study . Twenty-five patients were treated with 500 mg/m2 amifostine intravenously before HD-RIT and 25 patients served as controls , who received physiologic saline solution . Xerostomia was grade d according to World Health Organization ( WHO ) criteria . RESULTS Before HD-RIT in 25 control patients , uptake of technetium-99 m (99mTc)-pertechnetate was 0.45 
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However , there was insufficient evidence to show a difference when looking at stimulated salivary flow rates .
There was insufficient ( very low- quality ) evidence to show that amifostine compromised the effects of cancer treatment when looking at survival measures .
There was low- quality evidence that amifostine is associated with increases in : vomiting ( RR 4.90 , 95 % CI 2.87 to 8.38 ; P < 0.00001 , 5 studies , 601 participants ) ; hypotension ( RR 9.20 , 95 % CI 2.84 to 29.83 ; P = 0.0002 , 3 studies , 376 participants ) ; nausea ( RR 2.60 , 95 % CI 1.81 to 3.74 ; P < 0.00001 , 4 studies , 556 participants ) ; and allergic response ( RR 7.51 , 95 % CI 1.40 to 40.39 ; P = 0.02 , 3 studies , 524 participants ) .We found insufficient evidence ( that was of very low quality ) to determine whether or not pilocarpine performed better or worse than a placebo or no treatment control for the outcomes : xerostomia , salivary flow rate , survival , and quality of life .
There was some low- quality evidence that pilocarpine was associated with an increase in sweating ( RR 2.98 , 95 % CI 1.43 to 6.22 ; P = 0.004 , 5 studies , 389 participants ) .We found insufficient evidence to determine whether or not palifermin performed better or worse than placebo for : xerostomia ( low quality ) ; survival ( moderate quality ) ; and any adverse effects .
There is some low- quality evidence to suggest that amifostine prevents the feeling of dry mouth in people receiving radiotherapy to the head and neck ( with or without chemotherapy ) in the short- ( end of radiotherapy ) to medium-term ( three months postradiotherapy ) .
However , it is less clear whether or not this effect is sustained to 12 months postradiotherapy .
There was insufficient evidence to show that any other intervention is beneficial