Sotorasib selectively and irreversibly inhibits the Kirsten rat sarcoma (KRAS) G12C mutant protein. This inhibition can result in accumulation of activated epidermal growth factor receptor (EGFR), which may drive resistance to sotorasib. Therefore, the combination of sotorasib with an EGFR inhibitor, such as panitumumab, might lead to more complete inhibition of tumor cell growth and survival. Early data for the combination of sotorasib and panitumumab from CodeBreaK 101 subprotocol H showed promising antitumor activity in chemorefractory metastatic colorectal cancer (mCRC). The objective of the current study is to evaluate whether the combination of sotorasib and panitumumab is superior to standard of care trifluridine/tipiracil or regorafenib in the setting of chemorefractory mCRC. CodeBreaK 300 (NCT05198934) is a global phase III randomized, open-label, active-controlled study of the efficacy and safety of oral sotorasib combined with intravenous panitumumab in patients with mCRC. Key eligibility criteria include mCRC with KRAS G12C mutation confirmed by central molecular testing of tumor biopsy, and at least 1 prior line of therapy. Patients must have received and progressed or experienced disease recurrence on or after fluoropyrimidine, irinotecan, and oxaliplatin given for metastatic disease unless ineligible in the opinion of the investigator. Approximately 153 patients will be enrolled and randomized 1:1:1 to receive either sotorasib 960 mg daily and panitumumab or sotorasib 240 mg daily and panitumumab or investigator's choice (trifluridine and tipiracil, or regorafenib). The primary endpoint is progression-free survival using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR). Key secondary endpoints include overall survival and objective response. Global enrollment is ongoing. NCT05198934. Medical writing support was provided by Tim Harrison, PharmD (Amgen Inc.). Amgen Inc. Amgen Inc.

Introduction: Preclinical data suggest that loss of p53 might influence epidermal growth factor receptor (EGFR) promoter activity in different tumour types. The clinical role of p53 status in colorectal tumours, however, is still controversial. In the present study we assessed the role of p53 abnormal expression in patients with colorectal tumours treated with anti-EGFR therapy. Methods: Tumour samples from RAS/BRAF WT patients with colorectal tumours treated with second-third line irinotecan-cetuximab were analysed for the immunohistochemical expression of p53. Aim of the present study was to evaluate the correlation of p53 abnormal expression with clinical outcome in terms of OS, PFS, ORR. Tumour sidedness, EGFR promoter methylation and EGFR GCN were evaluated as covariates. The association between categorical variables has been estimated with the chi-squared test. Statistical analysis has been performed with the MedCalc package. Survival distribution has been estimated by the Kaplan–Meier method. Comparison of survival curves has been performed with log-rank test. Logistic regression analysis has been used to assess the independent role of variables resulted significant at univariate analysis. Results: Eighty-eight patients were included in the study, 36/88 (40.9%) had abnormal expression of p53 (abnormal p53), 52/88 (59.1%) had normal expression of p53 (normal p53). Abnormal p53 status was more frequent in left sided tumours (88.9% vs 16.7% of abnormal p53 for left sided and right sided tumours respectively) whereas it was less frequent in EGFR promoter methylated tumours (19.4% vs 71.2% of abnormal p53 for methylated and unmethylated respectively) and in EGFR GCN<2.12 tumours (5.6% vs 57.7% of abnormal p53 for EGFR GCN≥2.12 and EGFR GCN<2.12 respectively). Median PFS was 8,00 (95% CI: 6,98 to 8,10) vs 3,00 (95% CI: 2.90 to 3,63) months in patients with abnormal p53 tumours and in patients with normal p53 tumours respectively (HR 0.36; p < 0.0001). Median OS was 18 (95% CI:) vs 8 (95% CI: 6.98 to 8.10) months in patients with abnormal p53 tumours and in patients with normal p53 tumours respectively; HR: 0.21; p < 0.0001). ORR was 61.1%VS 3.8% in patients with abnormal p53 tumours and in patients with normal p53 tumours respectively (p < 0.0001). In multivariate analysis, EGFR promoter methylation and p53 expression maintained their independent role for OS (p:0.0003, Exp(b):0.21 and p:0.01, Exp(b):2.82 respectively) whereas only EGFR promoter methylation resulted independently correlated with PFS (p:0.025, Exp(b):3.03 and p:0.056, Exp(b):0.51 for EGFR promoter methylation and p53 expression respectively). Conclusion: The crosstalk between p53 and EGFR represents a poorly understood issue which could be significant in clinical practice. Our findings suggest a potential prognostic/predictive role of p53 status in patients with colorectal cancer treated with anti EGFR therapy. Further studies are needed to better understand the clinical role of p53 status in this setting.

Background: The fear of loss of dignity is a recurring concern among oncological patients, especially in the advanced stage of illness, for those who are in advanced stage of their disease. Chochinov has made the model of Dignity Therapy (DT) used primarily with people who were terminally ill. It consists of a short-term psychotherapy intervention that includes 3 major issues: physical aspects related to the disease and symptoms; existential/spiritual based on the patient's life history; social relationships linked to the quality of the relationship between the patient, practitioners and family members. The DT is a multi-dimensional psychosocial intervention for patient-centered care and it depends on experiences of generativity and the pursuit of purpose and meaning. It invites patients to discuss issues that matter most or that they would (most) want mainly to remember. Methods: Since 2016 we applied to 4 patients the DT in the perspective of simultaneous care with metastatic disease, in psychological therapy and still in chemotherapy. We are using the Italian validate version of semi-structured interview. The intervention takes place in 3-4 meetings, lasting 1 hour each, after informed consent. The interview uses 10 core questions and the responses are used to create a written legacy document to family members. The DT session is audio-recorded, transcribed, edited and given back to the patient. Content includes lifetime events that are most significant in the life of the patient, who can later personalize adding photos, images, titles or more. Results: Because the our small sample, we do not have a statistically relevant data, but we have noticed that the common themes that emerge in patients mainly concern the attributed value to the affections and the family and the experiences that have contributed to building their identity. The introduction of topics such as dignity, searching for meaning, has proved to be a valuable tool for the development of the true meaning of one's life, despite the changes in the disease. Moreover, in some cases, it has contributed to allowing the person to find a way of self-reliance in relation to loved ones. Conclusion: In our experience, DT showed to be a new promising therapeutic intervention for suffering and distress at the end of life. The literature review finds robust evidence for DT's overwhelming acceptability, rare for any medical intervention, especially in psychosocial-spiritual care.

Introduction: The introduction of biological agents in cancer therapy is changing the progression of metastatic colorectal cancer. Currently, resistance to biological agents is an emerging problem; the progression of the disease is caused by the development of resistant clones. According to some authors, these clones can be re-sensitized to traditional and previously utilized chemotherapy agents. The results of the CORRECT study demonstrated the efficacy of regorafenib monotherapy in both KRAS wild type and mutant pretreated patients (pts). Two recent reports showed the potential of reintroduction of chemotherapy, even after treatment with regorafenib.Patients and methods: We performed a retrospective review of clinical data from patients treated with regorafenib at our institution between March 2012 and March 2013. We analysed patient characteristics, KRAS/NRAS status, response to treatment (evaluated by RECIST v1.1 criteria) and survival.Results: Regorafenib was administered to 128 patients, and 11 (8.6%) received post-regorafenib therapy (to our knowledge). Seven (63.6%) patients were wild type for KRAS/NRAS. Post-regorafenib therapy represented for all the patients at least the fourth line: all the pts received both oxaliplatin- and irinotecan-based chemotherapy, all of them were treated with bevacizumab, and 7 patients also received cetuximab. Eight patients (72.7%) were treated with standard chemotherapy after regorafenib (irinotecan monotherapy, capecitabine plus oxaliplatin or irinotecan, dacarbazine or raltitrexed), while 3 patients received an experimental therapy (clinical trial). Nine of the 11 (81.8%) patients had PD and 2 patients had SD. The median progression-free survival was 1.6+ months (range 0.5-3.5), the median OS post-regorafenib was 2.1+ months (range 0.5-10.2) and the 6-month OS was 27.3%.Conclusion: Our retrospective analysis showed that after regorafenib therapy, re-introduction of chemotherapy is possible. Unfortunately, we reported a high percentage of disease progression beyond regorafenib, which is likely due to the high percentage of heavily pretreated patients (some received four or five types of therapy before regorafenib). We think that regorafenib could represent a chemotherapy resensitizing agent; however, additional studies are needed in patients who have received less pretreatment.

Background: In recent years, literature has reported an increase in the use of Complementary Alternative Medicine (CAM) by cancer patients to manage symptoms related to the disease or side effects of the treatments. Yoga is one of the most widely used complementary and alternative medicine therapies to cope with the most common symptoms of cancer as anxiety, depression, fatigue and sleep disorders. Recent studies conducted with cancer patients indicate that Yoga is associated with improvement in overall QOL, emotional well-being, physical symptoms and distress. In April 2013 we started the "Yoga project in Oncology " which involved the use of specific exercises of this discipline as a complement of cancer treatments. The aim of this study was to evaluate the impact of Yoga training on mood, fatigue and sleep quality in metastatic cancer patients. Material and methods: The Yoga intervention used the Yoga Ratna approach, consisting of pranayama (breathing exercises), gentle yoga asanas (postures) and meditation. The program includes 8 weekly group meetings lasting 1.5 hours, trained by a Yoga professional teacher with a psychologist. At the beginning (T0) and at the end (T1) of the training we administered the following tests: Hospital Anxiety and Depression Scale (HADS) to evaluate anxiety and depression; Fatigue Symptom Inventory (FSI) to assess fatigue symptoms; Pittsburgh Sleep Quality Index (PSQI) to assess sleep quality. Results: Sample consisted of 35 patients with metastatic cancer receiving chemotherapy. The majority of the patients were women (65.7%), the mean age was 55 years, 62.8% of patients were married and 45.7% were employed with a medium-high level of education (57.1%). All patients had advanced disease: 54.3% breast cancer, 31.4% colorectal cancer; 8.6% others gastrointestinal tumors and 5.7% pancreatic cancer. The preliminary results showed a not statistically significant trend concerning anxiety and depression improvement and a better sleep quality. In addition, we found an increase of fatigue symptoms. Conclusions: These results don't show statistically significant correlations probably because the still small sample treated so far. Moreover patients continued to receive medical treatment (chemotherapy) during Yoga training and this condition could have influenced their fatigue perception. Nevertheless, every participant expressed a very positive evaluation of this experience concerning a better body awareness and anxiety control.

The case is reported of a female patient who, at the age of 13 years (1993), was affected by a mild hepa-tosplenomegaly, ascribed to congenital hepatic fibrosis, associated to vascular and biliary malformations, with-out any portal hypertension signs. The appearance of epigastric mass with subjective feeling of delay in gastric emptying made necessary further radiological and bioptical investigations because a malignant hepatic tumor was suspected (2005-2006). It was documented a huge polilobulated and hypervascularized mass involving the left hemiliver, with hepatocellular regenerative nodules and perinodular fibrosis associated to vascular malfor-mations (left branch of hepatic artery hypertrophic, trunk and main left branch of portal vein not visible). At the age of 26 years (2006) she underwent a left hemihepatectomy. The macroscopic examination of the surgical specimen revealed a multinodular hepatic parenchyma. At the hepatic hilum it was also observed the hepatic artery (left branch) with a larger diameter and the portal vein (left branch) with a reduced diameter. The arterial branch had a winding course with a lot of collateral vessels and artero-venous shunts. The histological examina-tion of the surgical specimen confirmed the diagnosis of regenerative benign hepatic lesion (hepatic lobar nodu-lar hyperplasia), probably due to a portal hypoperfusion, whose cause is still unknown. The postoperative course was uneventful and the patient was discharged clinically recovered after 12 days from the surgery. Even though for 4 years she is in good conditions and the periodic radiological controls are constantly negative, it is wiser to continue the clinical follow up in order to avoid the possible appearance of new lesions, regenerative or a different kind of, involving the residual hepatic parenchyma.

Lung cancer is the leading cause of cancer-related mortality in both men and women and approximately 219,440 new cases of nonsmall cell lung cancer (NSCLC) were estimated to occur in the USA in 2009, which caused 159,390 NSCLC-related deaths. More than 50% of cases of advanced NSCLC are diagnosed in patients older than age 65, and recent Surveillance Epidemiology and End Results (SEERs) data suggest that the median age at diagnosis is 70 years. Until recently, the disease has been undertreated in this patient population, with a perception among many clinicians that elderly patients do not tolerate chemotherapy or radiotherapy. So, single agent chemotherapy is the recommended approach by the ASCO and International Expert Panels in unselected patients. The introduction of novel targeted therapies, such as Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitors (TKIs) which improved survival versus placebo in patients who had previously failed on chemotherapy, gives clinicians new, effective, and better tolerated options to consider when treating NSCLC in elderly patients. This paper describes the advances of EGFR TKIs for elderly patients with advanced NSCLC.

Gemcitabine and oxaliplatin have been demonstrated to have synergistic activity in several human cancer cell lines and varying patterns of toxicity. Gemcitabine is a very well tolerated drug with mild myelosuppression, asthenia and nausea/vomiting as its main toxicities. On the other hand, cumulative peripheral neurotoxicity is the main side effect of oxaliplatin. Therefore, there is a strong preclinical rationale to combine gemcitabine and oxaliplatin (Gemox) and to test this regimen as an alternative approach to gemcitabine with cisplatin or carboplatin as a treatment for different tumors. By reviewing the literature we found that the Gemox regimen seems to be active in the treatment of various kinds of tumors and is well tolerated. Further studies, especially to determine the optimal schedule, are clearly warranted. In addition, we report here our single-institution experience with this combination as salvage treatment for heavily pretreated cancer patients.

The use of the Monoclonal Antibodies (MoAbs) Bevacizumab (B) and Trastuzumab (T) beyond clinical progression in colorectal and breast cancer treatment is among the hottest topics in today's clinical oncology. Both observational and prospective studies, based on a sound preclinical basis, seem to support the notion that, simply replacing the cytotoxic drugs combined with the two MoAbs would provide an additional clinical benefit without stopping the biological agent. The aim of this review is to provide a critical analysis of the available clinical data, while waiting for the confirmatory prospective clinical trials still ongoing. The strength and the weakness of this innovative strategy, as well as the associated expense and toxicity issues will be discussed.

The anti-epidermal growth factor receptor monoclonal antibodies cetuximab and panitumumab have established efficacy as single agent and in combination with chemotherapy in advanced colorectal cancer. However, only a small percentage of unselected patients (around 10%) are responsive to these costly agents. Mutations in the KRAS gene are associated with resistance to both cetuximab and panitumumab and account for approximately 30% to 40% of resistant patients. Nevertheless, having an intact KRAS is necessary but not sufficient to derive benefit from EGFR inhibition. Further, positive predictive markers that are currently being evaluated include an increase in EGFR gene copy number and additional data suggest that other EGFR downstream pathways such as the PI3K/PTEN/AKT/mTOR and JAK/STAT pathways are also important when considering mechanisms of EGFR antibody resistance. New data seem to support the role of BRAF mutational status. In addition, high mRNA levels of the EGFR-ligands Epiregulin and Amphiregulin have been associated with increased responsiveness to cetuximab. In this article we will review the available clinical and experimental data potentially useful for a better patients' selection.

The anti-epidermal growth factor receptor monoclonal antibodies cetuximab and panitumumab have established efficacy as single agent and in combination with chemotherapy in advanced colorectal cancer. However, only a small percentage of unselected patients (around 10%) are responsive to these costly agents. Mutations in the KRAS gene are associated with resistance to both cetuximab and panitumumab and account for approximately 30% to 40% of resistant patients. Nevertheless, having an intact KRAS is necessary but not sufficient to derive benefit from EGFR inhibition. Further, positive predictive markers that are currently being evaluated include an increase in EGFR gene copy number and additional data suggest that other EGFR downstream pathways such as the PI3K/PTEN/AKT/mTOR and JAK/STAT pathways are also important when considering mechanisms of EGFR antibody resistance. New data seem to support the role of BRAF mutational status. In addition, high mRNA levels of the EGFR-ligands Epiregulin and Amphiregulin have been associated with increased responsiveness to cetuximab. In this article we will review the available clinical and experimental data potentially useful for a better patients' selection.

20721 Background: Cetuximab and panitumumab have demonstrated clinical activity in CRC treatment. However, their use is associated with dermatologic reactions of varying severity. The impact on HRQoL of these toxicities is still partially unknown. SD-29 is an extensively studied HRQoL instrument in dermatological disease (Chren. Arch Dermatol 1997), consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point Likert scale (from: “never” to “all the time”, higher scores indicate worse effects on QoL). Methods: We performed an exploratory cross-sectional study aimed to test SD-29 questionnaire in 25 pts with advanced CRC experiencing at least a grade II (NCI-CTC) skin rash and treated with at least 8 weeks of cetuximab (21 pts) or panitumumab (4 pts) in combination with chemotherapy or as monotherapy (6 pts) for metastatic CRC. Results: Among the 21 evaluable pts, mean score for emotions, symptoms and functioning was 14.1, 21.3 and 15.7, respectively (published mean scale scores for healthy volunteers: 9.2, 13.8 and 3.7, respectively, Lasek. Arch Dermatol 1998). Looking at single specific items dealing with sex life interference or to be ashamed or angered or closeness with loved ones due to skin conditions, < than 10% of pts answered 4 or 5 (“often” and “all the times”). Conclusions: SD-29 seems to be an useful tool for the assessment of HRQoL during anti-EGFr inhibitors therapies. A prospective comparison or integration with EORTC QLQ-C30 is warranted. No significant financial relationships to disclose.

1127 Background: TNBC (ER, PR, HER2 negative) pts can be treated with conventional chemotherapy only. The combination of 5- FU (350 mg/m2 iv bolus day 1 to 3), L (100 mg/m2 iv day 1 to 3) and N (20–25 mg/m2 bolus on day 1 and 3) every 3 weeks is an active regimen in metastatic breast cancer (MBC) (Nolè et al., Ann Oncol 1997). Methods: Among 137 consecutive MBC pts routinely treated at our Institution with the FLN regimen since 1999, 26 (19%) had TNBC. Median age was 61 yrs, prior adjuvant CT: 88%, one line of CT for MBC: 42%, Visceral involvement: 80%, >2 metastatic sites: 52%. Results: Efficacy data of FLN regimen are reported in Table 1. Response rate, TTF and OS among 105 evaluable non-TNBC pts treated during the same period with FLN were 48%, 7 mos and 19 mos, respectively. Among the 26 TNBC pts, neutropenia was the most frequent toxicity (NCI-CTCv2 grade IV in 32% of pts), with neutropenic fever in 3 cases (one toxic death). Nausea, vomiting and anorexia were mild to moderate in 35% of pts. Grade II ileus occurred in 4 pts, whereas grade II alopecia was reported in 15% of pts. Conclusions: Albeit based on a retrospective analysis, our data suggests that FLN is an effective and reasonably well tolerated combination chemotherapy for the palliative treatment of TNBC pts pretreated with an A±T based regimen. FLN regimen: Results N° Adj CT First line CT CR/PR/NC * RR% TTF (mos) OS (mos) 15 # A(11)A+T(3) 2/6/3 53 8 14 11 § A(8)A+T(1) T(8)Cddp(3) 1/3/3 36 5 11+ Total 26 A(19)A+T(4) 3/9/6 46 6.5 12 # first line for MBC, § second line CT for MBC, A: Anthracycline-based, T: Taxane-based, Cddp: Cisplatin-based, * Recist criteria. No significant financial relationships to disclose.

Although anthracyclines and the taxanes comprise the most active first-line cytotoxic treatments in patients with hormone-insensitive or life-threatening metastatic breast cancer, many patients progress and require other chemotherapeutic agents. Platinum compounds have shown activity in a broad spectrum of human tumors in vitro and in vivo. For patients with metastatic breast cancer resistant to anthracyclines or taxanes, or who have received anthracyclines with or without taxanes in the adjuvant or neoadjuvant setting, no standard regimen exists and platinum-based chemotherapy is one of the several options available. Moreover, platinum compounds have shown synergistic activity with trastuzumab, a monoclonal antibody against overexpressing HER2 breast cancer. However, the definitive role of platinum compounds in the treatment of breast cancer is not yet well established and further trials are needed.

BACKGROUND/AIMS:Long-term survival in patients with cancer of the pancreatic head is disappointing. Surgery is the only curative therapy. Unfortunately the prognosis of resected patients (10-15%) is extremely poor due to loco-regional cancer recurrence (50%). Lymphatic and perineural invasion may account for local recurrence. Japanese studies have reported the importance of an extended lymphadenectomy during the classic Whipple exeresis (40% of patients present lymph node metastases).METHODOLOGY:At the General Surgical Clinic of Pavia University 20 patients (14 men, 6 women, mean age 62.4 yr) with pancreatic head cancer (17 adenocarcinoma, 1 lymphoma, 2 carcinoma) underwent Whipple's exeresis with a regional (peripancreatic or R1) and juxta-regional (para-aortic or R2) lymphadenectomy according to the Ishikawa technique, between 1996-2000. R1 nodes consisted of lymph nodes at the pylorus, superior pancreatic head, common bile duct, anterior pancreaticoduodenal region, inferior pancreatic head and superior mesenteric vessels. R2 nodes consisted of lymph nodes at the superior and inferior pancreatic body, mid colic region, common hepatic duct, celiac axis and para-aortic region.RESULTS:The wide dissection was quite easy in patients with a serious cholestatic disease. Intraoperative mortality was 0%. Operative mortality was 5%. Postoperative complications (20%) consisted of 1 sepsis, 1 hepato-renal syndrome with hepatic coma, 1 intestinal obstruction by adhesive bands, and 1 wound infection. Eight patients (40%) died during a mean follow-up period of 6 months (neoplastic recurrence 50%). Notwithstanding the advanced disease (stage III 50%; N1+ 50%), 12 patients (60%) had a median postoperative survival rate of 18.4 months (range 1-48 months) without neoplastic recurrence. Tumor diameter was less than 4cm in 83.3% of cases.CONCLUSIONS:An earlier diagnosis (with tumor diameter <4 cm) can improve pancreatic head cancer prognosis. A wide surgical exeresis with R2 lymph nodes clearance together with surrounding connective and nervous tissue can remove micrometastases and better control local recurrence.

Several developments in the past few years have incrementally progressed the field and provided additional insights into the management of advanced colorectal cancer. The equivalence of several front-line regimens based on fluorouracil, capecitabine, oxaliplatin, irinotecan, bevacizumab, and cetuximab has provided opportunities for increased tailoring of therapies for individual patients. Nevertheless, some patients may suffer from the adverse drug reactions which will probably be the main cause of chemotherapy failure. The goal of pharmacogenomics is to find correlations between clinical responses to drugs and the genetic profiles of patients. Genes which codify for the metabolism enzymes, receptor proteins, or protein targets of chemotherapy agents often present various genetic polymorphisms. An assay is already commercially available for genotypic testing of the enzyme UGT1A1 which is predictive of toxicity from irinotecan. The advent of high-throughput methodologies, such as microarrays, enables tumor samples to be profiled on a global scale. Genes which may represent molecular signatures of sensitivity to fluorouracil and oxaliplatin has been identified with DNA microarray analysis. Keywords: Colorectal cancer, pharmacogenomics, fluorouracil, capecitabine, oxaliplatin, irinotecan

The epidermal growth factor receptor (EGFR) provides survival signals and is overexpressed in the majority of colorectal cancer. Cetuximab is a recombinant human/mouse monoclonal antibody(MoAb) against EGFR, clinically active in the treatment of human colorectal cancer. Unlike the predictable correlation of response to trastuzumab, another MoAb clinically active in a subgroup of breast cancer patients expressing HER-2/neu, responses to cetuximab in EGFR-expressing colorectal cancer is not predictable.

The world population is getting increasingly older. In Western countries, lung cancer in the most frequent cancer and more than 50% of patients who contract non-small-cell lung cancer (NSCLC) are close to 70 years old. It is therefore fundamentally important that we identify an overall strategy of screening, diagnosis and therapy designed specifically for elderly patients. NSCLC research still has relatively little material dedicated exclusively to the elderly, but recently interest has been growing, possibly due to the positive results of the most recent trials (Elderly Lung Cancer Vinorelbine Study Group (ELVIS), Southern Italy Cooperative Oncology Group (SICOG), Multicenter Italian Lung Cancer in the Elderly Study (MILES)). In particular, the integration of geriatric and oncological information has led to better recognition of elderly candidates for more aggressive therapy which is usually reserved for younger patients, while recognizing more fragile patients who need only support therapy.

Controversies exist regarding the classification of the emetogenic potential of chemotherapeutic agents such as taxanes, gemcitabine and irinotecan and the antiemetic prophylaxis for acute emesis to be administered. Instead, no prophylaxis for delayed emesis has been suggested. A prospective, observational study was carried out in 103 Italian oncological centers to evaluate the prescriptions of antiemetics and the incidence of nausea and vomiting in patients submitted to these chemotherapy agents. Two hundred and nine patients treated with taxanes, 300 with gemcitabine and 93 with irinotecan were evaluated. For the prophylaxis of acute emesis a 5-HT3 antagonist alone or in combination with a corticosteroid was administered to 86.6% of patients receiving taxanes, to 59.3% of those receiving gemcitabine and to 96.8% of those submitted to irinotecan. 20% to 40% of patients received antiemetic prophylaxis for delayed emesis. In taxane-treated patients the incidence of acute vomiting and nausea was 6.2% and 27.3%, respectively, while in gemcitabine- and irinotecan-treated patients it was 6.0/33.4% and 17.9/58.9%, respectively. In conclusion, the study showed that almost all patients received prophylaxis for acute emesis and that there is overprescription of 5-HT3 antagonists. The incidence of acute emesis is low; therefore, randomized clinical trials are necessary to verify the utility of prophylaxis and to find the best antiemetic treatment.